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1日前
A $190 Billion Weight-Loss Boom Exposed a Tissue-Restoration Gap, and One Nasdaq Company Is Moving to Fill ItJuly 7, 2026 9:45 AM
PR Newswire (Canada) Issued on behalf of Conexeu Sciences Inc.Conexeu Sciences Inc. (NASDAQ: CNXU) completed the P.R.O.O.F phase of its CXU preclinical program, the evidence base behind a focused first move into a roughly $11 billion medical aesthetics injectable market, an opening the company argues today's tools were never built to reach.RENO, Nev., July 7, 2026 /CNW/ -- Equity Insider News Commentary, The weight-loss drug boom is one of the defining medical stories of the decade, and its second-order effects are only beginning to reshape adjacent markets. As millions of patients lose significant weight on GLP-1 therapies, they are encountering a form of facial and body volume loss the existing aesthetic toolkit was never built to restore, and the market to solve it is growing fast. Against that backdrop, Conexeu Sciences Inc. (NASDAQ: CNXU) has completed a preclinical milestone it frames as the evidence base for a focused entry into medical aesthetics, positioning itself as an early mover in a tissue-restoration gap the current injectable toolkit does not reach. Key TakeawaysConexeu Sciences Inc. (NASDAQ: CNXU) completed the P.R.O.O.F phase (Performance and Regeneration Outcomes of Flowable Collagen) of its CXU preclinical program, the evidence base behind its planned move into the roughly $11 billion medical aesthetics injectable market [2]The demand driver is substantial: the GLP-1 drug market reached roughly $79 billion in 2025 and is projected to more than double to about $190 billion by 2035, a wave that has exposed a tissue-restoration need today's tools were not built to reach [3]That opening has created a provider economy the company, citing third-party estimates, expects to grow from roughly $0.7 billion to $2.0 billion by 2030, which CXU is designed to serve as an early mover [4]CXU is advanced as a platform rather than a single product, with a first regulatory step via a predicate-based 510(k) targeted for Q1 2027, the FDA's faster review track built around a 90-day review target.Conexeu is moving into a market defined by established leaders, including AbbVie (NYSE: ABBV), Eli Lilly (NYSE: LLY), Galderma Group AG (OTC: GDERF), and Novo Nordisk (NYSE: NVO), each distinct, far larger, and none a proxy for ConexeuThe Gap the Weight-Loss Wave CreatedThe weight-loss drug market reached roughly $79 billion in 2025 and is projected to more than double to about $190 billion by 2035, by the company's cited figures. That success has produced an unintended consequence now widely discussed in dermatology and plastic surgery: rapid, significant weight loss can leave patients with facial and body volume loss that conventional injectables, designed to smooth lines or add modest volume, were never built to restore at the scale required.Conexeu's thesis is that this gap is not a niche. Citing third-party estimates, the company points to a provider economy tied to treating these GLP-1-related concerns growing from roughly $0.7 billion in 2025 to $2.0 billion by 2030. It sits atop a medical aesthetics injectable reference market the company sizes at roughly $11 billion."GLP-1 is one of the defining medical stories of a generation. Its success has created an entirely new patient, someone whose body has changed faster than the aesthetics industry was built to respond to. No existing injectable was designed for that gap. This phase of our preclinical program gives us the evidence base to potentially address this gap," said Miles Harrison, President and Chief Executive Officer of Conexeu Sciences.Those market figures are third-party projections that may prove inaccurate, and the company presents them as context rather than guarantees. But the strategic logic is clear: Conexeu is aiming at a problem created by someone else's success, and positioning itself where the incumbents' current products are least suited to compete.What P.R.O.O.F EstablishedThe catalyst behind the move is the completion of P.R.O.O.F, Conexeu's 12-month preclinical study and the milestone the company says moves CXU from a platform concept to a defined development strategy. It is expressly not a commercial launch and not a regulatory clearance; it is the point at which the company says it has the evidence base to commit to a focused entry into medical aesthetics and to lay out the path that follows.The company describes one completed study assessed across three evidence pillars, and reports that P.R.O.O.F met its objectives across all three at the milestone level: a small-volume facial application, which is the focus of the company's first move and the most familiar entry point in injectable aesthetics; a large-volume application, which the company frames as the opportunity with the least competition, with full detail reserved for a forthcoming release; and the mechanical performance a deliverable material must provide, with full detail to follow in published data.The deeper story here is not a milestone; it is a category. The fillers and neuromodulators that have defined aesthetics for two decades were built to smooth lines and add modest volume, not to restore structure at the scale significant GLP-1 weight loss can present. Conexeu positions CXU™ not as another filler but as a structural entrant: an extracellular matrix scaffold designed to provide a temporary framework a patient's own cells and signals can populate. Whether this becomes a distinct category, and whether CXU™ anchors it, will be settled by data and adoption still ahead, not by this milestone. That ambition is the company's stated position, Architecting Bioregeneration™: to help define the category on its structural axis.Conexeu is careful to bound these statements. These are preclinical, animal-model findings that have not been peer-reviewed, and the company states that clinical significance has not been established. Beyond confirming that the study met its objectives, it is not disclosing the specific models, quantitative analyses, or individual endpoints, saying it intends to preserve the integrity of a forthcoming scientific presentation and peer-reviewed publication.A Faster Regulatory PathPart of the investment framing rests on how Conexeu intends to reach the market. Rather than pursuing the multi-year studies a genuinely new category typically requires, the company is advancing a predicate-based 510(k), the FDA pathway built around a 90-day review target for devices deemed substantially equivalent to an already-cleared predicate. Conexeu has targeted that first submission for Q1 2027, subject to completion of required testing, manufacturing, documentation, and regulatory review.The company characterizes that first clearance as the entry point that establishes CXU commercially and the foundation from which it intends to move into aesthetics. As with any 510(k), there is no assurance the FDA will accept the submission as filed, agree the device is substantially equivalent to the identified predicate, or clear it within the anticipated timeframe.The Companies That Define This MarketConexeu is a preclinical-stage company and not directly comparable to the established names below. These comparisons are for industry context only; each company pursues a different technology and business model, several are far larger or further along, and none is a proxy for Conexeu or implies any partnership or comparable performance.AbbVie (NYSE: ABBV) makes BOTOX® Cosmetic and the JUVÉDERM® fillers, the injectables that built modern medical aesthetics. Through its Allergan Aesthetics unit, AbbVie has publicly positioned GLP-1 weight loss as a new source of aesthetic demand, citing its own market research that midface volume loss is the leading facial change these patients seek to restore. AbbVie marks the scale of the established aesthetics category that new tissue-restoration approaches are entering..Eli Lilly (NYSE: LLY) makes Mounjaro® and Zepbound®, the GLP-1 medicines powering the weight-loss wave now reshaping demand across aesthetics and dermatology. Lilly is one of the names investors most tie to that shift, the same shift drawing new attention to tissue restoration.Galderma Group AG (OTC: GDERF), makes Restylane® and Sculptra®, the injectables that anchor its pure-play dermatology-and-aesthetics model across medical and consumer skin markets. Galderma shows how a focused aesthetics leader scales.Novo Nordisk (NYSE: NVO) makes Ozempic® and Wegovy®, the GLP-1 therapies at the center of that same weight-loss wave. Novo is the name most investors already tie to the shift now reshaping demand across aesthetics and dermatology.The Bottom LineA completed preclinical study is a beginning, not a guarantee. Conexeu remains a preclinical-stage company whose device candidates are investigational, whose findings have not been peer-reviewed, and whose first regulatory submission is not expected until early 2027, subject to review. But the strategic thesis is coherent and timely: a generational weight-loss wave has opened a tissue-restoration gap the current toolkit does not fill, and Conexeu is moving to serve it with a platform it says now has an evidence base behind it. For investors tracking where the GLP-1 aftermath creates new markets, Conexeu's P.R.O.O.F milestone is a concrete data point, with peer-reviewed publication, the 510(k) path, and market adoption the markers worth watching from here.SIGNAL OVER NOISESignal over noise. Aesthetics, weight-loss, and regenerative-medicine headlines move fast, and the crowd often moves first. Eagle Eye is a real-time investor signal-intelligence platform that surfaces sentiment shifts, news flow, and trending tickers as they happen, so you see the move forming instead of reading about it later. See it at eagle-eye.dev.CONTACT
Equity Insider
info@equity-insider.comSOURCES
[1] Conexeu Sciences Inc., "Conexeu Completes the Preclinical Data (P.R.O.O.F) Behind Its Move Into Medical Aesthetics as a Platform" (news release, RENO, Nev., 2026; CXU platform; P.R.O.O.F 12-month preclinical study; anticipated 510(k) Q1 2027).
[2] Grand View Research, Aesthetic Injectable Market Report (approximately $11.0 billion injectable aesthetics reference market).
[3] Morgan Stanley, weight-loss drug (GLP-1) market outlook (roughly $79 billion in 2025 to approximately $190 billion by 2035).
[4] Boston Consulting Group, "Five Growth Imperatives for Medical Aesthetics in Times of Uncertainty," August 2025 (GLP-1-related aesthetic provider revenue $0.7 billion in 2025 to $2.0 billion by 2030).
[5] AbbVie Inc. (NYSE: ABBV), Eli Lilly and Company (NYSE: LLY), Galderma Group AG (OTC: GDERF), and Novo Nordisk A/S (NYSE: NVO), corporate and product disclosures, 2026.DISCLAIMERNothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed for Market IQ Media Group Limited, a company incorporated under the laws of Ireland ("MIQL"), which wholly owns and operates Equity Insider. MIQL has been paid a fee for Conexeu Sciences Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of Conexeu Sciences Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. MIQL and its owner/operators do not own any shares of Conexeu Sciences Inc., but reserve the right to buy and sell shares of Conexeu Sciences Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQL has been reviewed and approved on behalf of Conexeu Sciences Inc. by CDMG. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Ten-Minute Tissue™ and the CXU™ platform are investigational device candidates and have not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. The P.R.O.O.F study is a preclinical, animal-model study; preclinical results are not necessarily predictive of results in humans, have not been peer-reviewed, and clinical significance has not been established.FORWARD-LOOKING STATEMENTS: This publication contains forward-looking statements, including statements regarding the CXU™ platform and Ten-Minute Tissue™; the early-stage, preclinical nature of the company's device candidates and the inherent uncertainty of preclinical and clinical development, including the possibility that preclinical results may not be predictive of clinical outcomes and that study objectives described as met may not translate into clinical benefit, regulatory clearance, or commercial success; the investigational status of CXU™, which is not cleared or approved in any jurisdiction; risks associated with the planned 510(k) submission, including that it may not be completed within the anticipated Q1 2027 timeframe or at all, and that the FDA may request additional information or determine the device is not substantially equivalent to the identified predicate; the size, growth, and addressability of the markets referenced, which are third-party estimates that may prove inaccurate; and the pace and degree of market adoption. Forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially. Except as required by law, the company undertakes no obligation to update any forward-looking statement. References to other companies are based on those companies' public disclosures, are provided for industry context only, and do not imply any partnership, endorsement, affiliation, or comparable performance. CXU™, Ten-Minute Tissue™, and B.R.E.A.S.T.™ are trademarks of Conexeu Sciences Inc. or its subsidiaries. View original content to download multimedia:https://www.prnewswire.com/news-releases/a-190-billion-weight-loss-boom-exposed-a-tissue-restoration-gap-and-one-nasdaq-company-is-moving-to-fill-it-302819380.html Original: A $190 Billion Weight-Loss Boom Exposed a Tissue-Restoration Gap, and One Nasdaq Company Is Moving to Fill It
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1週前
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental VitiligoJune 29, 2026 3:00 AM
PR Newswire (US) If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune diseasePositive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies, in which upadacitinib achieved both co-primary endpoints demonstrating at least a 50% improvement in total body repigmentation (T-VASI 50) and at least a 75% improvement in facial repigmentation (F-VASI 75) from baseline at week 481NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The final European Commission decision is expected in the coming months. If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo."Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option."The CHMP positive opinion is supported by data from the ongoing Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV. Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.1 The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.1Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in NSV is not currently approved in the EU.About Vitiligo
Vitiligo is a chronic, autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time.2 It imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.3 Non-segmental vitiligo (NSV), the most common form of vitiligo afflicting approximately 84% of patients, is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.2,4-6 While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Despite its immune-mediated nature, vitiligo is often considered primarily a cosmetic problem, which can lead to stigma and psychological impact on patients' lives.7-9 Vitiligo management is anchored in three primary treatment goals: disease stabilization, repigmentation, and maintaining repigmentation.10,11 There are currently no approved systemic medicines specifically indicated for these treatment goals in vitiligo.About Viti-Up Clinical Trials
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.EU Indications and Important Safety Information about RINVOQ® (upadacitinib)12 IndicationsRheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Giant cell arteritisRINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Crohn's diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Important Safety InformationContraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose-dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.The most common serious adverse reactions were serious infections.The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.euGlobally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=2333218782&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.ReferencesAbbVie. Data on file ABVRRTI82545Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.xMazzei Weiss ME. Vitiligo: to biopsy or not to biopsy?. Cutis. 2020;105(4):189-190.Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease Stability in Segmental and Non-Segmental Vitiligo. Indian Dermatol Online J. 2021 Aug 2;13(1):60-63. doi: 10.4103/idoj.IDOJ_154_21. PMID: 35198469; PMCID: PMC8809159Hlaca N, Žagar T, Kaštelan M, Brajac l, Prpic-Massari L. Current concepts of vitiligo immunopathogenesis. Biomedicines. 2022;10(7):1639. doi:10.3390/biomedicines10071639Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi l. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015van Geel N, Speeckaert R, Taïeb A, et al. Worldwide expert recommendations for the diagnosis and management of vitiligo: position statement from the International Vitiligo Task Force part 1: towards a new management algorithm. J Eur Acad Dermatol Venereol. 2023;37(11):2173-2184. doi:10.1111/jdv.19451Seneschal J, Boniface K. Vitiligo: Current therapies and future treatments. Dermatol Pract Concept. 2023;13(4S2):e2023313S. doi:10.5826/dpc.1304S2a313RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026Media: Mary Byunmary.byun@abbvie.comInvestors: Liz Shealiz.shea@abbvie.com View original content:https://www.prnewswire.com/news-releases/abbvie-receives-positive-chmp-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-and-adolescents-with-non-segmental-vitiligo-302812429.htmlSOURCE AbbVie Original: AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo
US Market News
1週前
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental VitiligoJune 29, 2026 3:00 AM
PR Newswire (US) If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune diseasePositive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies, in which upadacitinib achieved both co-primary endpoints demonstrating at least a 50% improvement in total body repigmentation (T-VASI 50) and at least a 75% improvement in facial repigmentation (F-VASI 75) from baseline at week 481NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The final European Commission decision is expected in the coming months. If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo."Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option."The CHMP positive opinion is supported by data from the ongoing Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV. Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.1 The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.1Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in NSV is not currently approved in the EU.About Vitiligo
Vitiligo is a chronic, autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time.2 It imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.3 Non-segmental vitiligo (NSV), the most common form of vitiligo afflicting approximately 84% of patients, is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.2,4-6 While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Despite its immune-mediated nature, vitiligo is often considered primarily a cosmetic problem, which can lead to stigma and psychological impact on patients' lives.7-9 Vitiligo management is anchored in three primary treatment goals: disease stabilization, repigmentation, and maintaining repigmentation.10,11 There are currently no approved systemic medicines specifically indicated for these treatment goals in vitiligo.About Viti-Up Clinical Trials
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.EU Indications and Important Safety Information about RINVOQ® (upadacitinib)12 IndicationsRheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Giant cell arteritisRINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Crohn's diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Important Safety InformationContraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose-dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.The most common serious adverse reactions were serious infections.The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.euGlobally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=2333218782&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.ReferencesAbbVie. Data on file ABVRRTI82545Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.xMazzei Weiss ME. Vitiligo: to biopsy or not to biopsy?. Cutis. 2020;105(4):189-190.Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease Stability in Segmental and Non-Segmental Vitiligo. Indian Dermatol Online J. 2021 Aug 2;13(1):60-63. doi: 10.4103/idoj.IDOJ_154_21. PMID: 35198469; PMCID: PMC8809159Hlaca N, Žagar T, Kaštelan M, Brajac l, Prpic-Massari L. Current concepts of vitiligo immunopathogenesis. Biomedicines. 2022;10(7):1639. doi:10.3390/biomedicines10071639Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi l. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015van Geel N, Speeckaert R, Taïeb A, et al. Worldwide expert recommendations for the diagnosis and management of vitiligo: position statement from the International Vitiligo Task Force part 1: towards a new management algorithm. J Eur Acad Dermatol Venereol. 2023;37(11):2173-2184. doi:10.1111/jdv.19451Seneschal J, Boniface K. Vitiligo: Current therapies and future treatments. Dermatol Pract Concept. 2023;13(4S2):e2023313S. doi:10.5826/dpc.1304S2a313RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026Media: Mary Byunmary.byun@abbvie.comInvestors: Liz Shealiz.shea@abbvie.com View original content:https://www.prnewswire.com/news-releases/abbvie-receives-positive-chmp-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-and-adolescents-with-non-segmental-vitiligo-302812429.htmlSOURCE AbbVie Original: AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo
US Market News
1週前
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia AreataJune 29, 2026 3:10 AM
PR Newswire (US) Positive CHMP opinion is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of Severity of Alopecia Tool (SALT) score ≤ 20 and key secondary endpoints, including improvements in eyebrows and eyelashes, at week 241,2Upadacitinib is the first JAK inhibitor to meet the stringent ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241,2NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA). The final European Commission decision is expected in the coming months."Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata." The CHMP positive opinion is supported by data from the ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. Both the 15 mg and 30 mg doses of upadacitinib in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥?80% scalp hair coverage compared with placebo. Key secondary endpoints were also met for both doses in both studies, including complete scalp hair regrowth (SALT = 0) at week 24. The safety profile of both doses of upadacitinib in Period A was generally consistent with that observed in approved indications.1,2Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in AA is not currently approved in the EU. About Alopecia Areata
Alopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.3,4 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.5,6 About UP-AA Clinical Trial
UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in alopecia areata is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.EU Indications and Important Safety Information about RINVOQ® (upadacitinib)7 IndicationsRheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Giant cell arteritisRINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Crohn's diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Important Safety InformationContraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:65 years of age and older;patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);patients with malignancy risk factors (e.g. current malignancy or history of malignancy)Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose-dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.The most common serious adverse reactions were serious infections.The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu.Globally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3647225048&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.ReferencesAbbVie. Data on file ABVRRTI81580.AbbVie. Data on file ABVRRTI81456.Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190.Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026Media:Mary Byunmary.byun@abbvie.comInvestors: Liz Shealiz.shea@abbvie.com View original content:https://www.prnewswire.co.uk/news-releases/abbvie-receives-positive-chmp-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-and-adolescents-with-severe-alopecia-areata-302812442.html Original: AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia Areata
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1週前
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia AreataJune 29, 2026 3:10 AM
PR Newswire (US) Positive CHMP opinion is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of Severity of Alopecia Tool (SALT) score ≤ 20 and key secondary endpoints, including improvements in eyebrows and eyelashes, at week 241,2Upadacitinib is the first JAK inhibitor to meet the stringent ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241,2NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA). The final European Commission decision is expected in the coming months."Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata." The CHMP positive opinion is supported by data from the ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. Both the 15 mg and 30 mg doses of upadacitinib in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥?80% scalp hair coverage compared with placebo. Key secondary endpoints were also met for both doses in both studies, including complete scalp hair regrowth (SALT = 0) at week 24. The safety profile of both doses of upadacitinib in Period A was generally consistent with that observed in approved indications.1,2Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in AA is not currently approved in the EU. About Alopecia Areata
Alopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.3,4 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.5,6 About UP-AA Clinical Trial
UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in alopecia areata is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.EU Indications and Important Safety Information about RINVOQ® (upadacitinib)7 IndicationsRheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Giant cell arteritisRINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Crohn's diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Important Safety InformationContraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:65 years of age and older;patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);patients with malignancy risk factors (e.g. current malignancy or history of malignancy)Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose-dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.The most common serious adverse reactions were serious infections.The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu.Globally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3647225048&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.ReferencesAbbVie. Data on file ABVRRTI81580.AbbVie. Data on file ABVRRTI81456.Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190.Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026Media:Mary Byunmary.byun@abbvie.comInvestors: Liz Shealiz.shea@abbvie.com View original content:https://www.prnewswire.co.uk/news-releases/abbvie-receives-positive-chmp-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-and-adolescents-with-severe-alopecia-areata-302812442.html Original: AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia Areata
US Market News
2週前
AbbVie to Acquire Apogee Therapeutics, Deepening Immunology PortfolioJune 22, 2026 7:05 AM
PR Newswire (US) Proposed acquisition adds a diverse pipeline of assets focused on elevating the standard of care for patients with dermatologic, respiratory and other related inflammatory and immunological diseasesApogee's lead asset, zumilokibart (APG777), is a late-stage, half-life extended monoclonal antibody targeting IL-13, in development for patients with atopic dermatitisApogee's pipeline also includes combinations of its novel antibodies; APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP), is being developed in asthmaApogee shareholders to receive $135.11 per share in cash, for a total equity value of approximately $10.9 billionAbbVie to hold investor conference call today, June 22, at 8:00 a.m. CTNORTH CHICAGO, Ill. and SAN FRANCISCO and BOSTON, June 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Apogee Therapeutics (NASDAQ: APGE) ("Apogee") today announced they have entered into a definitive agreement under which AbbVie will acquire Apogee and its diverse pipeline of multiple clinical-stage candidates in development across inflammatory and immunological diseases, including atopic dermatitis (AD) and asthma. The acquisition complements AbbVie's existing immunology portfolio and accelerates AbbVie's clinical presence in the respiratory space.Under the terms of the transaction, AbbVie will acquire all outstanding shares of Apogee for $135.11 per share in cash. The transaction values Apogee at a total equity value of approximately $10.9 billion. The boards of directors of both companies have unanimously approved the transaction. This transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including Apogee shareholder approval and receipt of regulatory approvals."For more than two decades, AbbVie has led and shaped the field of immunology bringing the science, scale and expertise needed to address some of the most complex diseases," said Robert A. Michael, chairman and chief executive officer, AbbVie. "The acquisition of Apogee further builds on our existing leadership, strengthening our ability to deliver innovative medicines to patients who need better options while also creating significant long-term value for shareholders. Apogee's pipeline adds highly differentiated clinical-stage assets, further expanding our robust immunology portfolio in areas of significant patient need, including atopic dermatitis and asthma. With our deep scientific expertise and proven capabilities, we are uniquely positioned to rapidly advance these programs and continue to transform the standard of care in inflammatory diseases."This acquisition holds potential for substantial shareholder value creation with mega-blockbuster peak sales potential across Apogee's pipeline of assets, including its lead asset, zumilokibart (APG777), a subcutaneous half-life extended monoclonal antibody targeting IL-13, being developed in AD and APG273, a combination of zumilokibart and APG333, an anti-TSLP half-life extended monoclonal antibody, being developed in asthma."This transaction reflects the strength of Apogee's vision, our team's dedication and the significant progress we've made advancing zumilokibart and our differentiated pipeline," said Michael Henderson, M.D., chief executive officer, Apogee. "Since our founding, we've focused on developing transformative therapies for patients with inflammatory diseases while creating value for shareholders. This transaction delivers substantial shareholder value and positions our programs to reach their full potential. We are deeply grateful to the patients, physicians and investigators who helped make this milestone possible. We believe AbbVie can advance zumilokibart and our portfolio while expanding their impact for patients worldwide."Zumilokibart targets IL-13, a critical cytokine in type 2 inflammation, and a central driver of inflammatory diseases like AD and asthma. Specifically in AD, a large majority of patients do not achieve simultaneous itch and skin improvement which represents an opportunity for the development of novel treatments that not only provide better skin clearance and itch resolution but also improve convenience with less frequent dosing. In its Phase 2 clinical trial, zumilokibart attained clinically significant results, with approximately two-thirds of patients on treatment achieving significant skin clearance at 16 weeks, along with notable improvements in itch reduction and overall disease control. These findings support its potential best-in-category profile, including strong efficacy and significantly improved dosing, in patients with AD. Longer-term data from the same trial also supports highly convenient maintenance regimens of either quarterly or twice a year dosing. The safety profile of zumilokibart is favorable and consistent with other medicines in its class, and the molecule has the potential to be evaluated in several additional inflammatory indications.Beyond zumilokibart, Apogee has built a broader pipeline of novel antibodies targeting multiple validated inflammatory pathways. APG273 combines zumilokibart with APG333, an antibody that blocks TSLP, a signaling protein that acts as an early trigger of inflammation in the lungs. Phase 1 data showed that APG333 has a long half-life and was able to suppress relevant type 2 inflammatory markers for up to six months after dosing. The Phase 1 data with APG333 and positive interim results from a phase 1b study of zumilokibart in asthma, supports the potential of the APG273 combination with quarterly or twice-yearly injections in asthma.Transaction Terms
Under the terms of the definitive agreement, AbbVie will acquire all outstanding Apogee common stock for $135.11 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by Apogee shareholders. Fairmount Funds Management LLC and Venrock Associates have entered into voting agreements in support of the transaction.The proposed transaction is expected to be accretive to AbbVie's adjusted diluted earnings per share (EPS) beginning in 2032.AbbVie Conference Call Details
AbbVie will host an investor conference call today, June 22, at 8:00 a.m. CT to discuss this transaction. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 9:00 a.m. CT. Presentation materials for the investor conference call are available here.Advisors
AbbVie's financial advisor is Morgan Stanley & Co. LLC and Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as legal advisor.Apogee's financial advisors are Jefferies LLC and Goldman Sachs & Co. LLC, and Kirkland & Ellis LLP is serving as legal advisor.About AbbVie in ImmunologyAbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=1410214967&u=https%3A%2F%2Fprotect.checkpoint.com%2Fv2%2Fr01%2F___https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F___.YXAzOmFwb2dlZXRoZXJhcGV1dGljczpjOm9mZmljZTM2NV9lbWFpbHNfYXR0YWNobWVudDo5YzI0MTIwMjkyOGEyODA3MDk5YTQ1YzlmNDA5ZjE5ZTo3OmJlYjY6NGQ4MmY1MmM2OGQ2NGIzM2ZjMmZmNmVhYWQ2ZjZjYmI5OGE3YThiZDAyZmFiZWVhNWQ4NjgxM2ZhYWQ1ZDY0ZDpwOlQ6Rg&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.About Apogee TherapeuticsApogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, Chronic Obstructive Pulmonary Disease (COPD) and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart, the company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma and EoE. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit https://apogeetherapeutics.com.Cautionary Statement Regarding Forward-Looking StatementsThis communication contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. All statements other than statements of historical fact, including statements regarding market and industry prospects and future results of operations or financial position made in this communication are forward-looking. In many cases, you can identify forward-looking statements by terminology, such as "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of such terms and other comparable terminology. Statements in this communication that are forward-looking may include, but are not limited to, statements regarding the benefits of the proposed acquisition of Apogee Therapeutics, Inc. ("Apogee") by AbbVie Inc. ("AbbVie") and the associated integration plans, anticipated future operating performance and results of Apogee, the expected accretion to AbbVie's adjusted diluted earnings per share beginning in 2032, the expected timing of the closing of the proposed acquisition and other transactions contemplated by the merger agreement governing the proposed acquisition (the "Merger Agreement"), and the potential of zumilokibart (APG777) and other Apogee's pipeline assets.There may also be other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are difficult to predict and are generally outside Apogee's control, that could cause actual performance or results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. Such risks and uncertainties include, but are not limited to: the occurrence of any event, change or other circumstance that could give rise to the right of Apogee or AbbVie or both of them to terminate the Merger Agreement, including circumstances requiring a party to pay the other party a termination fee pursuant to the Merger Agreement; the failure to obtain applicable regulatory or Apogee stockholder approval in a timely manner or otherwise; the risk that the proposed acquisition may not close in the anticipated timeframe or at all due to one or more of the other closing conditions to the transaction not being satisfied or waived; the possibility of competing acquisition proposals for Apogee; the risk that there may be unexpected costs, charges or expenses resulting from the proposed acquisition; risks related to the ability of Apogee and AbbVie to successfully integrate the businesses and the possibility that such integration may be more difficult, time consuming or costly than expected; risks that the proposed transaction disrupts Apogee's or AbbVie's current plans and operations; the risk that certain restrictions during the pendency of the proposed transaction may impact Apogee's ability to pursue certain business opportunities or strategic transactions; risks related to disruption of each company's management's time and attention from ongoing business operations due to the proposed transaction; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Apogee's and/or AbbVie's common stock, credit ratings or operating results; the risk that the proposed transaction and its announcement could have an adverse effect on the ability of Apogee and AbbVie to retain and hire key personnel, to retain customers and to maintain relationships with each of their respective business partners, suppliers and customers and on their respective operating results and businesses generally; the risk of litigation that could be instituted against the parties to the Merger Agreement or their respective directors, managers or officers and/or regulatory actions related to the proposed acquisition, including the effects of any outcomes related thereto; the risk that zumilokibart (APG777) or APG273 and other Apogee's pipeline assets may not demonstrate the anticipated success, safety, or efficacy in ongoing or future clinical trials; the risk that positive Phase 2 and Phase 1b interim results for zumilokibart (APG777) may not be predictive of results in later-stage or larger clinical trials; challenges to intellectual property; adverse litigation or government action; competition from other products; difficulties inherent in the research and development process; risks related to unpredictable and severe or catastrophic events, including but not limited to acts of terrorism, war or hostilities, cyber attacks, or the impact of any pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide on Apogee's or AbbVie's business, financial condition and results of operations, as well as the response thereto by each company's management; and other business effects, including the effects of industry, market, economic, political or regulatory conditions.Also, AbbVie's and Apogee's actual results may differ materially from those contemplated by the forward-looking statements for a number of additional reasons as described in AbbVie's and Apogee's filings with the Securities and Exchange Commission (the "SEC"), including those set forth in the Risk Factors section and under any "Forward-Looking Statements" or similar heading in AbbVie's and Apogee's most recently filed Annual Report on Form 10-K filed on February 20, 2026 and March 2, 2026, respectively, and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.AbbVie and Apogee have based these forward-looking statements on their current expectations and projections about future events. Although the parties believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate. As a result, the forward-looking statements based upon those assumptions also could be incorrect. Except to the extent required by law, AbbVie and Apogee undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Additional Information and Where to Find ItThis communication is being made in respect of the proposed transaction involving Apogee and AbbVie. A meeting of the stockholders of Apogee will be announced as promptly as practicable to seek Apogee stockholder approval in connection with the proposed transaction. Apogee intends to file relevant materials with the SEC, including preliminary and definitive proxy statements relating to the proposed transaction. The definitive proxy statement will be mailed to Apogee's stockholders. This communication is not a substitute for the proxy statement or any other document that may be filed by Apogee with the SEC.BEFORE MAKING ANY DECISION, APOGEE STOCKHOLDERS ARE URGED TO CAREFULLY READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE INTO THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.Any vote in respect of resolutions to be proposed at Apogee's stockholder meeting to approve the proposed transaction or other responses in relation to the proposed transaction should be made only on the basis of the information contained in Apogee's proxy statement. You will be able to obtain a free copy of the proxy statement and other related documents (when available) filed by Apogee with the SEC at the website maintained by the SEC at www.sec.gov or by accessing the Investors section of Apogee's website at https://investors.apogeetherapeutics.com.No Offer or SolicitationThis communication is for informational purposes only and is not intended to, and does not constitute or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.Participants in the SolicitationApogee, AbbVie and their respective directors and executive officers and certain of their employees may be deemed to be participants in the solicitation of proxies from Apogee's stockholders in connection with the proposed transaction. Information regarding Apogee's directors and executive officers is set forth under the captions "Proposal 1: Election of Directors," "Corporate Governance," "Executive Officers," "Executive Compensation" and "Certain Information About Our Common Stock" in the definitive proxy statement for Apogee's 2026 Annual Meeting of Stockholders, filed with the SEC on April 24, 2026, and in Apogee's Current Reports on Form 8-K, filed with the SEC on April 24, 2026 and June 12, 2026. Information regarding AbbVie's directors and executive officers is set forth under the captions "Information Concerning Director Nominees," "The Board of Directors and its Committees," "Director Compensation," "Securities Ownership" and "Executive Compensation" in the definitive proxy statement for AbbVie's 2026 Annual Meeting of Stockholders, filed with the SEC on March 23, 2026, and in AbbVie's Current Report on Form 8-K, filed with the SEC on May 12, 2026. To the extent holdings of Apogee's securities and AbbVie's securities by their respective directors or executive officers have changed since the amounts set forth in such filings, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. These documents may be obtained free of charge from the SEC's website at www.sec.gov or by accessing the Investors section of Apogee's website at https://investors.apogeetherapeutics.com and the Investors section of AbbVie's website at https://investors.abbvie.com. Additional information regarding the interests of participants in the solicitation of proxies in connection with the proposed transaction will be included in the proxy statement that Apogee expects to file in connection with the proposed transaction and other relevant materials Apogee may file with the SEC. AbbVie ContactsMedia:Marianne Ostrogorskimarianne.ostrogorski@abbvie.com Investors: Liz Shealiz.shea@abbvie.com Apogee ContactsMedia:Andi Rose / Aura Reinhard
Joele Frank, Wilkinson Brimmer Katcher(212) 355-4449 Investors: Noel Kurdi
VP, Investor Relationsnoel.kurdi@apogeetherapeutics.com Dan Budwick
1AB Media
dan@1abmedia.com
View original content:https://www.prnewswire.co.uk/news-releases/abbvie-to-acquire-apogee-therapeutics-deepening-immunology-portfolio-302806304.html Original: AbbVie to Acquire Apogee Therapeutics, Deepening Immunology Portfolio
US Market News
1月前
AbbVie Announces European Commission Authorization of Expanded Label for VENCLYXTO® (venetoclax) to Include Additional Combinations in Previously Untreated Chronic Lymphocytic LeukemiaMay 29, 2026 8:00 AM
PR Newswire (US) Addition of VENCLYXTO plus acalabrutinib, with or without obinutuzumab, and VENCLYXTO plus ibrutinib supported by data from Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trialFixed-duration VENCLYXTO-based combination regimens provide patients with additional CLL treatment options that may offer the potential for treatment-free intervals NORTH CHICAGO, Ill., May 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has authorized an expanded label for VENCLYXTO® (venetoclax) to include use in combination with acalabrutinib (with or without obinutuzumab) and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The expanded label follows the EC's inclusion of these combinations in the acalabrutinib and ibrutinib labels. These all-oral, fixed-duration combination regimens support current standards of care and offer patients and providers additional targeted oral medications for CLL in the first-line setting that include the potential for time off treatment.The European Commission authorization extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.1"VENCLYXTO-based combination regimens have demonstrated a favorable efficacy and safety profile in the first-line setting for chronic lymphocytic leukemia," said Svetlana Kobina, MD, PhD, vice president, global medical affairs, oncology, AbbVie. "The inclusion of additional fixed-duration, chemotherapy-free, oral VENCLYXTO combinations in the label helps address the evolving needs of patients and healthcare providers, as they consider disease management options with the potential for treatment-free intervals. AbbVie is committed to transforming standards of care for people living with cancer, and the availability of all-oral VENCLYXTO combinations expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL."VENCLYXTO in combination with acalabrutinib (with or without obinutuzumab) was supported by data from the Phase 3 AMPLIFY trial. VENCLYXTO in combination with ibrutinib was supported by data from the Phase 3 GLOW and Phase 2 CAPTIVATE trials."While CLL remains an incurable cancer and patients often relapse, it can be effectively managed with combination regimens, which have emerged as effective options to reduce the treatment burden for patients living with this disease," said Paolo Ghia, MD, PhD, Professor of Medical Oncology at the Università Vita-Salute San Raffaele, AMPLIFY and CAPTIVATE steering committee member and investigator. "With demonstrated durable responses in previously untreated patients and opportunity for treatment-free periods, these additional venetoclax-based combination regimens expand options for patients without the need for time-consuming infusions or continuous therapy." CLL is one of the most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). Even with recent improvement in outcomes, patients living with CLL can still encounter difficult decisions when selecting the treatment option that best suits their individual needs."People living with chronic lymphocytic leukemia can face multiple challenges when it comes to managing their disease, which can take a toll on a patient's mental health and overall well-being," said Jan Rynne, interim association development lead, European CLL Association. "The possibility of time off treatment through additional combination treatment options has critical quality of life implications for patients and their families as they continue to navigate everyday life with CLL." For a full list of side effects and information on dosage and administration, contraindications and other precautions when using VENCLYXTO in combination with acalabrutinib (with or without obinutuzumab) and use in combination with ibrutinib for the treatment of adult patients with previously untreated CLL, please refer to the Summary of Product Characteristics for further information.2About the AMPLIFY StudyThe AMPLIFY (NCT03836261) study is a randomized, global, multicenter, open-label Phase 3 trial evaluating the efficacy and safety of the fixed-duration combination regimen of VENCLYXTO and acalabrutinib, with or without obinutuzumab, compared to chemoimmunotherapy in adult patients with previously untreated CLL without del(17p) or TP53 mutation.3Results showed that the fixed-duration combination regimen of VENCLYXTO and acalabrutinib was superior to chemoimmunotherapy. Study results showed the combination regimen reduced the risk of disease progression or death by 35% versus chemoimmunotherapy. Median progression-free survival (PFS) was not reached versus 47.6 months for chemoimmunotherapy. The triplet regimen including obinutuzumab also demonstrated clinically meaningful efficacy, with median PFS likewise not reached. The safety profiles of the combination regimens were consistent with the known safety profiles of each individual therapy alone. No new safety signals were observed in the AMPLIFY study.4The most common adverse reactions (≥15%) of any grade in patients who received VENCLYXTO and acalabrutinib were headache (35%), diarrhea (33%), musculoskeletal pain (25%), COVID-19 (21%), fatigue (18%), bruising (17%), rash (16%), and nausea (15%). The most common laboratory abnormalities (≥15%) of any grade were neutrophils decreased (78%), glucose increased (74%), lymphocytes decreased (56%), platelets decreased (43%), hemoglobin decreased (35%), calcium decreased (30%), ALT increased (26%), urate increased (25%), LDH increased (24%), potassium increased (22%), AST increased (22%), ALP increased (20%), glucose decreased (20%), creatinine increased (19%), and sodium increased (15%). Grade 4 laboratory abnormalities in >15% of patients included absolute neutrophil count decreased (15%).Serious adverse reactions occurred in 25% of patients receiving VENCLYXTO and acalabrutinib. The most common serious adverse reactions (≥2%) were COVID-19, including COVID-19 pneumonia (9%), second primary malignancies (2.7%) and neutropenia (2.1%). Fatal adverse events occurred in 3.4% of patients. The most common fatal adverse events included COVID-19 and COVID-19 pneumonia.About the GLOW StudyThe GLOW (NCT03462719) study is a randomized, open-label Phase 3 trial comparing progression-free survival in patients treated with the fixed-duration combination regimen of VENCLYXTO and ibrutinib or chlorambucil plus obinutuzumab in adult patients with previously untreated CLL.5Results from the 64-month follow-up to the GLOW study showed that the fixed-duration combination regimen of VENCLYXTO and ibrutinib demonstrated a clinically meaningful improvement in PFS and overall survival (OS) compared to chlorambucil plus obinutuzumab for older patients and/or those with comorbidities with previously untreated CLL. At 64 months of follow-up, VENCLYXTO and ibrutinib reduced the risk of disease progression or death by 73% compared to chlorambucil plus obinutuzumab. For OS, the regimen reduced the risk of death by 54%. Study results showed a median PFS of 65 months in the venetoclax plus ibrutinib arm versus 23 months in the chlorambucil plus obinutuzumab arm.6The safety profile of VENCLYXTO and ibrutinib was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Most common grade ≥3 treatment-emergent adverse events (AEs) were neutropenia (34.9%), infections (17%), and diarrhea (10.4%) for VENCLYXTO and ibrutinib; neutropenia (49.5%), infections (11.4%), and thrombocytopenia (20%) for chlorambucil plus obinutuzumab. Deaths during treatment occurred in seven patients on VENCLYXTO and ibrutinib and two patients on chlorambucil plus obinutuzumab. The VENCLYXTO and ibrutinib regimen was well-tolerated and no adverse events of tumor lysis syndrome (TLS) were observed in the venetoclax plus ibrutinib arm, compared to 6 cases in the chlorambucil with obinutuzumab arm. At 64-months follow-up, the time patients spent without significant toxicity or disease progression was significantly longer for VENCLYXTO and ibrutinib versus chlorambucil plus obinutuzumab (52 months vs 31 months). Treatment-emergent adverse event-free PFS (TEAE-free PFS) analysis showed that while patients receiving 15 months of VENCLYXTO and ibrutinib spent slightly more time in the grade 3/4 toxicity state versus patients receiving 6 months of chlorambucil plus obinutuzumab (2 months vs 1 month), patients who received VENCLYXTO and ibrutinib spent substantially more time in TEAE-free PFS (50 months vs 30 months), indicating longer disease control without significant toxicity.About the CAPTIVATE StudyThe CAPTIVATE (NCT02910583) study is a multicenter, two-cohort Phase 2 trial assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of VENCLYXTO plus ibrutinib in adult patients with previously untreated CLL or small lymphocytic lymphoma (SLL).7Results showed that the fixed-duration combination regimen of VENCLYXTO plus ibrutinib demonstrated 5.5-year PFS and overall survival (OS) rates of 66% and 97%, respectively; 73% of CLL patients remained treatment-free 5.5 years after 15 months of VENCLYXTO plus ibrutinib therapy.8The most common treatment-emergent AEs in patients who received VENCLYXTO plus ibrutinib were diarrhea (62%), nausea (43%), neutropenia (42%) and arthralgia (33%); AEs were primarily grade 1 or 2 in severity. The most common grade 3/4 AEs were neutropenia (33%), hypertension (6%) and neutrophil count decreased (5%). One fatal AE (sudden death) occurred during ibrutinib lead-in. Serious AEs occurred in 36 patients (23%).About VENCLYXTO VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.VENCLYXTO (venetoclax) EU Indication and Summary of Important Safety Information
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):in combination with acalabrutinib with or without obinutuzumabin combination with obinutuzumabin combination with ibrutinibVENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.VENCLYXTO monotherapy is indicated for the treatment of CLL:In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, orIn the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitorContraindications
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John's wort.Special Warnings & Precautions for Use
Tumour lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with CLL when treated with venetoclax. Venetoclax poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. During post marketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax. The risk of TLS is a continuum based on multiple factors, including comorbidities (particularly reduced renal function), tumour burden, and splenomegaly in CLL. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. Serious infections, including sepsis with fatal outcome, have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment and dose interruption or reduction, as appropriate. Live vaccines should not be administered during treatment or thereafter until B-cell recovery.Drug Interactions
CYP3A inhibitors: For patients requiring concomitant use with venetoclax, refer to the SmPC for recommendations for managing drug-drug interactions. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax.Additional agents that may alter venetoclax plasma concentrations include P-gp or BCRP inhibitors, CYP3A inducers (including St. John's wort), azithromycin and bile acid sequestrants. Concomitant use of these agents with venetoclax may require further dose adjustments and patients should be monitored closely for signs of toxicities.Adverse Reactions
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab, ibrutinib, or rituximab were diarrhoea, neutropenia, nausea, upper respiratory tract infection, fatigue and vomiting. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab, ibrutinib, or rituximab were pneumonia, febrile neutropenia, sepsis, neutropenia, anaemia, diarrhoea and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.The most commonly occurring adverse reactions (≥20%) of any grade in patients treated with venetoclax in combination with acalabrutinib were infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reaction (≥5%) was neutropenia.The most commonly occurring adverse reactions of any grade (≥20%) in patients treated with venetoclax in combination with acalabrutinib and obinutuzumab were infections, neutropenia, headache, bruising, diarrhoea, nausea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reactions (≥5%) were neutropenia and thrombocytopenia.Discontinuations, dosage reductions and dose interruptions due to adverse reactions have occurred in both venetoclax monotherapy and in combination therapy.Special Populations
Patients with reduced renal function (CrCl
US Market News
1月前
U.S. FDA Approves DECNUPAZTM (pivekimab sunirine-pvzy) for Treatment of Adult Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment OptionsMay 27, 2026 6:18 PM
PR Newswire (US) - DECNUPAZ is the first and only antibody-drug conjugate (ADC) approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN) that is initiated in an outpatient setting
- DECNUPAZ marks AbbVie's first ADC approved for blood cancerNORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZTM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN."For patients living with rare cancers, progress in research can be life-changing," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. "This approval delivers a new option for treating BPDCN and demonstrates our determination to drive meaningful advancements for patients affected by difficult-to-treat cancers."Patients with BPDCN often present with skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects adult men aged 60-70?years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options.1"BPDCN is an aggressive disease with historically limited therapeutic options, particularly for patients whose disease has relapsed or become refractory," said Naveen Pemmaraju, M.D., professor of leukemia, The University of Texas MD Anderson Cancer Center. "Pivekimab sunirine-pvzy is the first and only CD123 targeting ADC that can be initiated in an outpatient setting, offering a meaningful benefit for BPDCN patients in need of new treatment alternatives."In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNUPAZ demonstrated clinically meaningful and durable responses. In newly diagnosed patients with BPDCN (n=33), researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients (39.4%) who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease (n=51) had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients (11.8%) who were able to receive post-study treatment stem cell transplant.2Most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. DECNUPAZ has a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.About the CADENZA Trial
CADENZA is a Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and anti-leukemia activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN. The study was also designed to determine the maximum tolerated dose, recommended Phase 2 dose and dosing schedule for pivekimab sunirine-pvzy monotherapy.3 Results published in the Journal of Clinical Oncology included a total of 84 patients who were part of the trial. Of these, 33 patients with no CNS involvement received DECNUPAZ as a frontline treatment and 51 had relapsed or refractory disease without evidence of active CNS disease. Eleven patients in the frontline treatment group had prior or concurrent cancer diagnoses in addition to BPDCN, making their treatment more complex and challenging.2About DECNUPAZ (pivekimab sunirine-pvzy)
DECNUPAZ (pivekimab sunirine-pvzy) is a CD123-targeting ADC for the treatment of adult patients diagnosed with the hematological malignancy BPDCN. ADCs are designed to deliver potent cell death-inducing agents called 'payloads' directly to the cells expressing a specific protein. CD123 (IL-3Ra) is a protein overexpressed in BPDCN, making it an ideal target for therapy. The payload is a member of the indolinobenzodiazepine pseudodimer class that alkylates DNA and causes single-strand DNA breaks without crosslinking, leading to apoptosis and cell death.4In October 2020, the FDA granted pivekimab sunirine-pvzy Breakthrough Therapy Designation for relapsed/refractory BPDCN.DECNUPAZ U.S. Uses and Important Safety Information, Including Boxed Warning4Use
What is DECNUPAZ?
DECNUPAZ is a prescription medicine used to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).It is not known if DECNUPAZ is safe and effective in children.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about DECNUPAZ?
DECNUPAZ can cause serious side effects, including:Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver), which can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including:
- yellowing of the skin or eyes - pain in your stomach (abdomen)
- fast weight gain - swelling of your stomach
- dark urine
Your healthcare provider will check you for liver problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also delay or stop treatment with DECNUPAZ if you have severe liver problems.What should I tell my healthcare provider before receiving DECNUPAZ?
Tell your healthcare provider about all of your medical conditions, including if you:have liver problemsare allergic to sulfiteshave asthmahave kidney problemsare pregnant or plan to become pregnant. DECNUPAZ can harm your unborn baby.Females who are able to become pregnant:Your healthcare provider will check for pregnancy before you start treatment with DECNUPAZ.Use effective birth control (contraception) during treatment with DECNUPAZ and for 7 months after your last dose.Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with DECNUPAZ.Males who have female partners who are able to become pregnant:Use an effective birth control during treatment with DECNUPAZ and for 4 months after your last dose of DECNUPAZ.are breastfeeding or plan to breastfeed. It is not known if DECNUPAZ passes into your breast milk. Do not breastfeed during treatment with DECNUPAZ and for 1 month after the last dose.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect DECNUPAZ and increase your risk of side effects.What are the possible side effects of DECNUPAZ?DECNUPAZ can cause serious side effects, including:Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver), which can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including yellowing of the skin or swelling of your stomach.Infusion-related reactions (IRR). DECNUPAZ can cause serious, life-threatening infusion related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion of DECNUPAZ to help reduce infusion-related reactions. Your healthcare provider will check you for symptoms of infusion related reactions during your infusion and for at least 4 hours or longer if needed, after your first infusion, and for at least 1 hour after each of your next infusions. Tell your healthcare provider right away if you develop signs or symptoms of infusion related reactions, including:
- shortness of breath - nausea
- flushing - chest pain
- fever - feeling faint or lightheaded
- chills - vomitingFluid retention (edema). DECNUPAZ can cause your body to hold too much fluid during treatment. Your healthcare provider may prescribe water pills (diuretic) if you develop edema. Tell your healthcare provider if you develop new or worsening edema, including:swelling of your ankles or legsshortness of breath or difficulty breathingunusual weight gainSulfite allergic reactions. DECNUPAZ contains sodium metabisulfite, a sulfite that may cause severe, life-threatening allergic reactions in some people. Sulfite allergic reactions are more common in people with asthma than in people without asthma. Get medical help right away if you develop hives; itching; rash; swelling of the eyes, tongue, or lips; chest pain; trouble breathing or swallowing.The most common side effects include: fluid retention (edema)feeling tiredmuscle, bone, and joint pain bleedinginfusion-related reactionsnauseadiarrheaThe most common severe abnormal laboratory test results with DECNUPAZ include: decreased white blood cell countsdecreased platelet counts decreased red blood cell countsincreased blood sugar levelYour healthcare provider may decrease your dose, delay your infusion, or permanently stop treatment with DECNUPAZ if you have side effects.DECNUPAZ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.These are not all the possible side effects of DECNUPAZ. Call your doctor for medical advice about side effects.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.Please see full Prescribing Information, including BOXED WARNING.If you are having difficulty paying for your medicine, AbbVie may be able to help. Visitwww.AbbVie.com/PatientAccessSupport to learn more.About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at http://www.abbvie.com/oncology.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=998529263&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.References:Shimony, S. et al. Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): 2025 Update on Diagnosis, Pathophysiology, Risk Assessment, and Management. American Journal of Hematology. Published June 17, 2025. Available at https://onlinelibrary.wiley.com/doi/10.1002/ajh.27737. Accessed April 15, 2026.Pemmaraju, N. et al. Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). J Clin Oncol 44, 861-873(2026). Available at https://ascopubs.org/doi/10.1200/JCO-25-02083. Accessed April 15, 2026.Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN. Available at https://clinicaltrials.gov/study/NCT03386513. Accessed April 15, 2026.DECNUPAZ. Summary of Product Characteristics. AbbVie. U.S. Media:Matt SkryjaMatt.skryja@abbvie.comInvestors: Liz SheaLiz.shea@abbvie.com View original content:https://www.prnewswire.com/news-releases/us-fda-approves-decnupaztm-pivekimab-sunirine-pvzy-for-treatment-of-adult-patients-with-blastic-plasmacytoid-dendritic-cell-neoplasm-an-ultra-rare-and-aggressive-blood-cancer-with-limited-treatment-options-302783714.htmlSOURCE AbbVie Original: U.S. FDA Approves DECNUPAZTM (pivekimab sunirine-pvzy) for Treatment of Adult Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options
US Market News
2月前
AbbVie Announces New Data at ASCO 2026 Demonstrating Breadth and Momentum Across its Next-Generation Oncology PipelineMay 21, 2026 6:46 PM
PR Newswire (US) - Data from novel Top1i ADC and T-cell engager platforms highlight potential within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer, platinum-resistant ovarian cancer and multiple myeloma - NORTH CHICAGO, Ill., May 21, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it will present new data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago demonstrating the depth and breadth of its oncology pipeline. The data will be shared through multiple oral presentations and posters spanning solid tumors and blood cancer indications.Collectively, these presentations highlight AbbVie's continued focus on attacking cancer from inside and outside the cell, supported by sustained investment in its expanding antibody-drug conjugate (ADC) platform, including Topoisomerase I inhibitor (Top1i)–based ADCs and its T-cell engager (TCE) portfolio."Our oncology pipeline is intentionally designed to address the complexity and heterogeneity of cancer biology through a diversified portfolio of differentiated therapies spanning multiple modalities," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology. "The data we are presenting at ASCO reflect the strength of this strategy, including continued momentum with our ADC programs in solid tumors and validation of immune-based approaches, such as etentamig, being investigated as a next-generation TCE in multiple myeloma. These results underscore our commitment to advancing assets with distinct scientific approaches aimed to address critical unmet patient needs." Key findings presented include:Data from AbbVie's Top1i ADCs Across Solid Tumors:Metastatic castration-resistant prostate cancer (mCRPC): A first-in-human Phase 1 study (NCT06318273) evaluating ABBV-969, a potential first-in-class bispecific ADC targeting PSMA/STEAP1, in heavily pretreated patients with mCRPC, demonstrated a confirmed objective response rate (ORR) of 45% among 29 patients with RECIST-evaluable disease. At active dose levels, 67% of patients achieved at least a 50% reduction in prostate-specific antigen (PSA50), with 28% achieving PSA90 responses. The safety profile was manageable in heavily pretreated patients with mCRPC.1 Additional findings to be presented at the meeting.Small cell lung cancer (SCLC): In Phase 1 data (NCT05599984) of ABBV-706 (SEZ6-directed ADC) in the monotherapy cohort (n=17), SCLC patients receiving ABBV-706 at the recommended Phase 3 dose of 1.8 mg/kg as a second-line therapy achieved an objective response rate (ORR) of 82%— promising data in a disease where prognosis remains poor. The safety profile was comparable with previously reported data.2 Additional findings and updated data will be presented at the meeting. The findings support continued evaluation of ABBV-706 in SCLC.Platinum-resistant ovarian cancer (PROC) and head and neck squamous cell carcinoma (HNSCC): Data from a Phase 1 basket study of Telisotuzumab adizutecan (Temab-A), a next-generation c-Met–directed ADC, demonstrated antitumor activity of Temab-A monotherapy in biomarker unselected PROC (NCT06084481) and HNSCC (NCT06084481) patients.3,4 Additional observations in c-Met selected patients, to be presented at the meeting, highlight the potential of Temab-A in this population.3,4These new data support the potential of Temab-A across an expanding range of solid tumors and patient populations, including previously presented data in lung, colorectal and gastric cancers and across patients with MET-amplification and increased c-Met expression.Relapsed/refractory multiple myeloma (R/R MM): Data from a Phase 1b study of etentamig (NCT05650632), being investigated as a next-generation B-cell maturation antigen (BCMA) x CD3 T-cell engager, as monotherapy in a cohort of heavily pre-treated BCMA-exposed R/R MM patients will be presented at the meeting.Etentamig is an investigational BCMA and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.The data showed that among patients (n=11) that proceeded to etentamig after BCMA-directed CAR-T in the prior line of therapy, an ORR of 64% was achieved. Minimal residual disease (MRD) negativity was observed in 67% (2/3) of evaluable patients who received BCMA-directed therapy in the prior line of therapy. The median duration of response was 13 months. No new safety signals were observed. Despite no step-up dosing (SUD) in this cohort, all cytokine release syndrome (CRS) reported (57%) were grade 1 and 2.5 Additional findings to be presented at the meeting.Further information on AbbVie clinical trials is available at https://www.clinicaltrials.gov/.Additional details on key presentations are available below, and the full ASCO Annual Meeting 2026 abstracts are available here.TitleDate/Time SessionAbstract
Number Etentamig in patients (pts) with
relapsed/refractory multiple
myeloma (RRMM) with prior
exposure to B-cell maturation
antigen (BCMA)-targeted therapy.Friday, May 29 5:09-5:21
PM CDTOral Presentation Oral Abstract
Session HematologicMalignancies—
Plasma CellDyscrasia7508Phase 1 basket study of
telisotuzumab adizutecan
(Temab-A, ABBV-400), ac-Met protein-targeting antibody-
drug conjugate: Results from
patients with platinum-resistant
ovarian/primary
epithelial/fallopian tube cancer
(PROC).Saturday,
May 30 8:42-8:48
AM CDTRapid Oral
Abstract Session Gynecologic
Cancer5514A phase 2 randomized study
comparing telisotuzumab
adizutecan monotherapy with
standard of care in patients with
post-adjuvant circulating tumor
DNA-positive colorectal cancer.Saturday,
May 30 9:00 AM-
12:00 PM
CDTPoster Board:
447a Poster Session Gastrointestinal
Cancer—Colorectal
and AnalTPS3688 A Phase 2 study of telisotuzumab
adizutecan (ABBV-400; Temab-A)
in patients with advanced solid
tumors harboring MET
amplification.Saturday,
May 30 1:30-4:30
PM CDTPoster Board:
293a Poster Session Developmental
Therapeutics—
Molecularly
Targeted Agents
and Tumor BiologyTPS3157 Phase 1 basket study of
telisotuzumab adizutecan (ABBV-
400, Temab-A), a c-Met protein-
targeting antibody-drug
conjugate: Results from patients
with head and neck squamous
cell carcinoma (HNSCC).Saturday,
May 30 1:30-4:30
PM CDT Poster Board:
484 Poster Session Head and Neck
Cancer 6027 Telisotuzumab adizutecan
(Temab-A) plus osimertinib (osi)
as 1L treatment for
unresectable/metastatic NSCLC.Sunday,
May 31 9:00 AM-
12:00 PM
CDTPoster Board:
451a Poster Session Lung Cancer—Non-Small Cell
MetastaticTPS8663 Impact of MET amplification
(amp) on telisotuzumab vedotin
(Teliso-V) efficacy and safety in
2L+ non-squamous (NSQ) EGFR
wild-type (WT) NSCLC with c-Met
protein overexpression (OE).Sunday,
May 31 9:00 AM-
12:00 PM
CDTPoster Board: 314 Poster Session Lung Cancer—Non-Small Cell
Metastatic8524 AndroMETa-Lung-713: A phase
2/3 study of telisotuzumab
adizutecan (ABBV-400, Temab-A)
vs standard of care (SOC) in
patients with epidermal growth
factor receptor (EGFR)-mutated
non-small cell lung cancer
(NSCLC).Sunday,
May 31 9:00 AM-
12:00 PM
CDTPoster Board:
450a Poster Session Lung Cancer—Non-Small Cell
MetastaticTPS8661 SEZanne: A phase 2 randomized,
open-label, multicenter study to
evaluate the optimal dose, safety,
and efficacy of ABBV-706 in
combination with atezolizumab
(atezo) versus standard of care
(SOC) in patients (pts) withpreviously untreated extensive-
stage (ES) small cell lung cancer
(SCLC).Sunday,
May 31 9:00 AM-
12:00 PM
CDTPoster Board:
603a Poster Session Lung Cancer—Non-
Small Cell Local-
Regional/Small
Cell/Other
Thoracic CancersTPS8135 A phase 1, first-in-human (FIH)
study evaluating the safety,
pharmacokinetics, and efficacy of
ABBV-969 in patients with
metastatic castration-resistant
prostate cancer (mCRPC).Sunday,May 31 4:42-4:48
PM CDTRapid Oral
Abstract Session GenitourinaryCancer—Prostate,
Testicular,and Penile5014A single-arm, phase 2 study of
neoadjuvant mirvetuximab
soravtansine and carboplatin for
FRa-expressing advanced-stage
serous epithelial ovarian, fallopian
tube, or primary peritoneal cancer
(M25-231; NCT06890338; GOG-3115).Monday,
June 1 9:00 AM-
12:00 PM
CDTPoster Board:
296b Poster Session Gynecologic
CancerTPS5633ABBV-706 as monotherapy and in
combination with budigalimab in
patients with relapsed/refractory
(R/R) small cell lung cancer (SCLC).Monday,June 1 3:39-3:51
PM CDTOral Presentation Oral Abstract
Session Lung Cancer—Non-
Small Cell Local-
Regional/Small
Cell/Other
Thoracic Cancers8008Phase 1, first-in-human (FIH)
study evaluating safety and
efficacy of ABBV-706: Results
from patients with high-grade
central nervous system (CNS)
tumors.Monday,June 1 1:30-4:30
PM CDTPoster Board: 406 Poster Session Central Nervous
System Tumors2041 A US-based, retrospective,
observational study of biomarker
testing patterns across lines of
therapy in patients with
metastatic colorectal cancer.N/APublication Only Gastrointestinal
Cancer –
Colorectal and
Anale15526Timing of biomarker testing and
associated clinical outcomes in
ovarian cancer patients: A
retrospective study.N/APublication Only Gynecologic
Cancere17574Real-world (RW) characteristics
and outcomes in platinum-
resistant ovarian cancer (PROC)
patients treated with
mirvetuximab soravtansine
(MIRV) monotherapy or single-
agent chemotherapy (CTx).N/APublication Only Gynecologic
Cancere17606Telisotuzumab adizutecan (Temab-A), etentamig, ABBV-969, and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.U.S. Prescribing Information for AbbVie MedicinesPlease see full Prescribing Information for ELAHERE™ (mirvetuximab soravtansine-gynx)
Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv)
Please see full Prescribing Information for EPKINLY® (epcoritamab -bysp)About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3802347322&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2Fposts%2F%3FfeedView%3Dall&a=LinkedIn" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube. About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Dorff T, Peer A, Sharma M, et al. A phase 1, first-in-human (FIH) study evaluating the safety, pharmacokinetics, and efficacy of ABBV-969 in patients with metastatic castration-resistant prostate cancer (mCRPC). Abstract 5014presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois.Byers L, Cho B, Cooper A, et al. ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). Abstract 8008 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois.Fleming G, Kurnit K, Pelster M, et al. Phase 1 basket study of telisotuzumab adizutecan (Temab-A, ABBV-400), a c-Met protein-targeting antibody-drug conjugate: Results from patients with platinum-resistant ovarian/primary peritoneal/fallopian tube cancer (PROC). Abstract 5514 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois.Villaflor V, Harding J, Mahadevan D, et al. Phase 1 basket study of telisotuzumab adizutecan (Temab-A, ABBV-400), a c-Met protein-targeting antibody-drug conjugate: Results from patients with head and neck squamous cell carcinoma (HNSCC). Abstract 6027 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois.Chhabra S, Searle E, Popat R, et al. Etentamig in patients (pts) with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)-targeted therapy. Abstract 7508 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois.Contacts:
Media:Investors:
Sourojit (Jit) Bhowmick, Ph.D. Liz Shea
jit.bhowmick@abbvie.com liz.shea@abbvie.com
View original content:https://www.prnewswire.com/news-releases/abbvie-announces-new-data-at-asco-2026-demonstrating-breadth-and-momentum-across-its-next-generation-oncology-pipeline-302779632.htmlSOURCE AbbVie Original: AbbVie Announces New Data at ASCO 2026 Demonstrating Breadth and Momentum Across its Next-Generation Oncology Pipeline
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2月前
Next-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesMay 13, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesBioMedWire Editorial Coverage: Obesity and type 2 diabetes mellitus ("T2DM") rank among the most urgent and costly healthcare problems facing the world today, contributing to surging rates of cardiovascular disease, fatty liver disease, kidney complications and ballooning healthcare expenses. What once represented a specialized class of diabetes treatments has grown into one of the most consequential therapeutic categories in modern medicine, with GLP-1 receptor agonists now fundamentally restructuring how obesity, metabolic disease and potentially even neurodegeneration are treated. Operating in this environment is SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) (Profile), which through its subsidiary GlucaPharm Inc. is developing a distinct next-generation GLP-1 platform built around GEP-44, a novel triple agonist peptide engineered to improve efficacy, tolerability, and delivery flexibility within one of the most commercially dynamic pharmaceutical markets in history. SureNano is one of the emerging microcap companies active in the GLP-1 space, operating alongside established leaders including Merck & Co. Inc. (NYSE: MRK), AbbVie Inc. (NYSE: ABBV), Viking Therapeutics Inc. (NASDAQ: VKTX) and Altimmune Inc. (NASDAQ: ALT).SureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs.The commercial potential tied to GLP-1 therapies is expanding quickly, with the global GLP-1 market forecast to potentially reach $190 billion by 2035.SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence.Preclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies.Beyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio.Click here to view the custom infographic of the SureNano Science editorial. Rewriting the Rules of Metabolic MedicineThe global obesity crisis shows no sign of plateauing. According to the World Health Organization ("WHO"), a reported one billion people globally are currently living with obesity, while type 2 diabetes rates continue to climb across both high-income and developing economies. The WHO further notes that obesity increases the risk of cardiovascular disease, stroke and T2DM, while further research has linked obesity to chronic kidney disease and rising healthcare expenditures, placing substantial and growing pressure on health systems around the world.GLP-1 receptor agonists have rapidly risen to become one of the defining breakthroughs in metabolic medicine. Originally introduced to manage blood glucose levels in diabetes patients, these drugs are now recognized for their capacity to drive meaningful weight reduction and deliver broad improvements in metabolic health. Market leaders Novo Nordisk A/S and Eli Lilly and Company have come to dominate the space through their blockbuster injectable franchises, including Ozempic(R), Wegovy(R), Mounjaro(R) and Zepbound(R).Commercial momentum in this space is increasing. JPMorgan Chase & Co. forecasts that the general obesity drug market could reach $200 billion by 2030 as global adoption expands and indications stretch beyond diabetes and weight management. Additional industry projections suggest GLP-1 therapies are on track to become one of the most commercially successful drug categories ever, with annual sales projections of $150 billion or more by the end of the decade.The industry is already pivoting toward the next generation of incretin therapies, with a focus on improved efficacy, tolerability and patient convenience. Needle-free, including oral, formulas, expanded indications and combination metabolic approaches have emerged as major priorities across the sector. SureNano Science is positioning itself in this scenario as a nimble participant pursuing differentiated innovation through GEP-44, a patented triple agonist peptide licensed from Syracuse University and designed to advance through the U.S. Food and Drug Administration ("FDA") regulatory route.A Next-Gen Candidate Built for Better OutcomesSureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs, positioning this up-and-coming microcap as a small but strategically focused company moving through the FDA process. Unlike traditional GLP-1 agonists, which act on a single receptor pathway, GEP-44 functions as a triple agonist targeting GLP-1 alongside peptide YY receptors Y1 and Y2. This combined mechanism is designed to simultaneously regulate glucose metabolism, reduce appetite and improve tolerability within a single therapeutic molecule.The compound originated at Syracuse University and has generated promising results in preclinical settings. According to research, GEP-44 produced meaningful reductions in food intake and decreased body weight while also enhancing glycemic control in preclinical models. In addition, the compound did not trigger the nausea, malaise and gastrointestinal adverse effects commonly seen with many first-generation GLP-1 therapies, a distinction that could become increasingly significant as patient populations and adherence demands grow.The broader pharmaceutical industry is investing aggressively in incretin therapies that can address tolerability and long-term adherence challenges. PwC reports that the next segment of the obesity drug market will most likely be characterized by expanded indications, more patient-friendly delivery formats and therapies with stronger adherence profiles. This lends itself to a supportive environment for companies pursuing second-generation GLP innovation.Despite being smaller than more-established pharmaceutical players, SureNano Science operates with a lean development model and cost-efficient structure built for flexibility and development speed. The company is involved in substantial research in Australia, where government incentive programs may provide research tax credits of up to 43.5% on qualifying expenditures. Should GEP-44 continue producing favorable results through clinical development, the company could emerge as an attractive acquisition, licensing or partnership candidate within the fast-expanding GLP ecosystem.Market Scale and the Commercial Case for GLP-1 InnovationThe commercial potential tied to GLP-1 therapies is expanding quickly. According to Morgan Stanley, the global GLP-1 market could reach $190 billion by 2035 as patient adoption broadens and therapeutic applications extend into new disease areas. Industry forecasts from BCC Research also forecast significant long-term growth, with the GLP-1 analogue market estimated to reach $268.4 billion by 2030.Patient uptake estimates that between 25 and 30 million Americans could be using GLP-1 therapies by 2030, up from approximately 10 million in 2026. Increasing insurance coverage along with obesity prevalence and growing physician familiarity are all driving the rapid mainstreaming of these treatments.At the same time, the competitive setting is shifting toward the next wave of products. IQVIA calls 2026 the "year of the orals," with oral GLP-1 formulations projected to meaningfully enhance accessibility, compliance and long-term maintenance therapy adoption. The anticipated off-patent expansion of semaglutide across major global markets is also expected to intensify competition while broadening overall patient access.As GEP-44 advances through IND-enabling studies and moves toward eventual phase 1 trials, SureNano Science stands as one of a small number of microcap public companies offering direct exposure to the expanding GLP-1 market. This positioning may represent a meaningful valuation gap relative to large-cap pharmaceutical incumbents and late-stage obesity therapy developers, particularly if the company achieves key clinical and regulatory milestones.Delivery Innovation as a Second Engine of ValueAlongside its core therapeutic development efforts, SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence. The company's platform strategy includes evaluating oral, sublingual and intranasal delivery approaches that could eventually reduce reliance on injectable administration.Convenience and adherence have emerged as increasingly important competitive dimensions within the GLP-1 market. The dominant therapies today are injection-based, creating barriers for some patients due to administration complexity, refrigeration requirements and long-term compliance challenges. Noninvasive and oral alternatives are widely regarded as representing one of the most significant near-term commercial opportunities in obesity and diabetes treatment.Industry analysts increasingly view delivery innovation as potentially as consequential as efficacy improvements. IQVIA notes that oral obesity therapies could substantially boost long-term maintenance adoption while simplifying supply chains by removing cold-chain requirements, factors that could meaningfully expand patient access in international markets.By combining therapeutic development with delivery innovation, SureNano Science is working to build a vertically integrated metabolic disease platform rather than advancing a single injectable drug candidate. This broader strategy may generate additional long-term optionality and commercial flexibility as the obesity treatment market continues to evolve.Preclinical Data Point to a Meaningful Competitive EdgePreclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies. According to the company, the compound demonstrated approximately 15% weight loss in preclinical testing, compared with roughly 9% observed with liraglutide, while food intake reductions reached approximately 39% versus around 20% for the comparator.In addition to weight reduction, GEP-44 produced improvements in glycemic control while reportedly avoiding nausea and vomiting during testing. Gastrointestinal side effects remain among the most frequently cited challenges associated with currently marketed GLP-1 therapies and represent a significant driver of discontinuation. Improved tolerability could therefore become a meaningful competitive advantage if these preclinical findings are validated in human studies.The pharmaceutical industry continues to pour resources into next-generation obesity therapies capable of delivering better outcomes and patient experiences. The Pharma Letter reports that obesity drug pipelines are increasingly oriented toward differentiation through combination receptor pathways, improved tolerability profiles, and expanded delivery options as the competitive field intensifies.While GEP-44 remains in preclinical development, these early findings place SureNano Science within a strategically important segment of the obesity treatment landscape. If subsequent studies continue to support these results, the company could establish itself as a distinctive participant in one of the largest and most rapidly expanding therapeutic categories in contemporary healthcare.Exploring Broader Platform Opportunities for Long-Term GrowthBeyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio. These discussions include nonbinding opportunities involving ibogaine-related intellectual property concentrated on formulation and delivery technologies.While still exploratory and not considered a core asset at this stage, the initiative reflects a broader strategic aim of building diversified platform capabilities across multiple high-growth therapeutic areas. Scientific and investor interest in ibogaine and related psychedelic-derived therapeutics has grown considerably in recent years, as researchers examine their potential applications in addiction treatment, mental health conditions, and neurological disorders.CNN recently reported on the growing scientific and regulatory attention being directed at ibogaine research, particularly in areas related to opioid addiction and treatment-resistant mental health conditions. The U.S. Food and Drug Administration has also signaled increasing openness to accelerating development pathways for treatments targeting serious mental illnesses and areas of significant unmet medical need.SureNano's interest in formulation and delivery technologies within these emerging areas fits naturally with the company's broader emphasis on drug-delivery innovation and platform versatility. Rather than treating ibogaine-related opportunities as a standalone commercial priority, the company appears to be assessing how specialized delivery technologies and intellectual property could complement its existing capabilities in metabolic therapeutics and nontraditional administration. This kind of optionality may provide incremental long-term strategic value if the regulatory landscape surrounding psychedelic-based therapies continues to evolve.These initiatives remain early stage and are subject to meaningful scientific, clinical and regulatory uncertainty. However, by selectively evaluating expansion opportunities alongside its primary GLP-1 development program, SureNano Science is aligning itself with a broader trend toward diversified therapeutic platforms capable of competing across multiple large and evolving healthcare markets. As pharmaceutical innovation increasingly converges around metabolic health, neuroscience, and advanced delivery technologies, strategic flexibility may prove to be a growing differentiator for emerging biotechnology companies.Advances Continue Across the GLP-1 LandscapeMomentum across the GLP-1 and metabolic disease sector continues to accelerate as leading biotechnology and pharmaceutical companies expand development programs targeting obesity, diabetes, liver disease and broader cardiometabolic conditions. Recent news from the GLP-1 space highlights continued investment in next-generation therapies, late-stage clinical development, strategic partnerships and regulatory progress as the rapidly evolving space remains one of the most closely watched areas in healthcare and biotechnology.Merck & Co. Inc. (NYSE: MRK) expanded into the GLP-1 and obesity-treatment market through an exclusive global licensing agreement with Hansoh Pharma for an investigational oral GLP-1 receptor agonist. Merck stated that the candidate is being developed for cardiometabolic diseases and described the agreement as part of the company's strategy to strengthen its presence in metabolic disorders. The company noted that it will receive exclusive rights outside China to develop, manufacture and commercialize the therapy, reflecting a growing industry focus on oral GLP-1 treatments for obesity and related conditions.AbbVie Inc. (NYSE: ABBV) announced positive topline results from a phase 1 multiple ascending dose study evaluating ABBV-295, its long-acting amylin analog being developed for obesity and metabolic disease treatment. AbbVie reported that ABBV-295 demonstrated "clinically meaningful" body weight reduction ranging from approximately 7.75% to 9.79% over the treatment period, while also showing a "favorable tolerability profile" with no serious adverse events reported. The company emphasized that the data support continued advancement of its metabolic disease pipeline amid increasing interest in next-generation obesity therapies that may complement or compete with GLP-1 drugs.Viking Therapeutics Inc. (NASDAQ: VKTX) reported completion of enrollment in its phase 3 VANQUISH-2 trial evaluating VK2735, its dual GLP-1/GIP receptor agonist candidate for obesity treatment. Viking stated that the study is assessing subcutaneous VK2735 in adults with obesity and type 2 diabetes, while concurrent phase 3 development is also ongoing in broader obesity populations. The company noted that VK2735 is being developed in both oral and injectable formulations for metabolic disorders, underscoring its position in the rapidly expanding GLP-1 obesity-treatment landscape.Altimmune Inc. (NASDAQ: ALT) announced that pemvidutide received FDA Breakthrough Therapy designation for the treatment of MASH, further advancing development of the company's GLP-1/glucagon dual receptor agonist platform. Altimmune stated that pemvidutide has demonstrated improvements in liver fat reduction, weight loss and fibrosis-related measures, while the company plans to initiate a Phase 3 trial evaluating multiple doses over a 52-week treatment period. The announcement reinforces Altimmune's ongoing efforts to position pemvidutide within the broader GLP-1 and metabolic disease sector spanning obesity, liver disease and related cardiometabolic conditions.Collectively, these developments underscore the growing importance of GLP-1-related therapies as companies compete to address some of the world's largest and fastest-growing chronic health challenges. With ongoing advances in oral formulations, combination therapies and expanded metabolic disease applications, the sector continues to attract significant scientific, clinical and investor attention while reshaping the future landscape of obesity and cardiometabolic treatment.For further information about SureNano Science Ltd., visit the SureNano Science profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. 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2月前
CNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchMay 13, 2026 9:00 AM
InvestorsHub NewsWireCNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchBioMedWire Editorial Coverage: Among the most guarded structures in human biology, the brain is also one of the hardest to treat. The blood-brain barrier ("BBB"), a specialized biological membrane, shields neural tissue from foreign substances, including most therapeutic agents. As cases of Alzheimer's disease climb worldwide and governments sharpen their focus on biodefense, the absence of efficient pathways for delivering drugs to the brain is fast becoming one of medicine's most pressing unresolved problems. Companies such as Oncotelic Therapeutics Inc. (OTCQB: OTLC) (Profile) are responding to this challenge with next-generation delivery platforms engineered to circumvent biological barriers and ensure direct, targeted access to the central nervous system ("CNS"). Oncotelic has developed a proprietary intranasal nose-to-brain ("N2B") system capable of rapidly shuttling therapeutics to the brain, a signal of growing industry consensus that delivery innovation, not merely drug discovery, will drive the next wave of breakthroughs in CNS medicine. Oncotelic joins a group of leading biopharma companies working in the biopharmaceutical and advanced therapeutics space, including Amgen Inc. (NASDAQ: AMGN), Johnson & Johnson (NYSE: JNJ), AbbVie Inc. (NYSE: ABBV) and Lunai Bioworks Inc. (NASDAQ: LNAI).While the blood-brain barrier is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers.Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain.CNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense.Designed as a device-enabled approach to direct CNS delivery, Oncotelic's N2B delivery system offers a potential alternative to traditional systemic or intramuscular routes.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base.Click here to view the custom infographic of the Oncotelic Therapeutics editorial.Why the Blood-Brain Barrier Is So Difficult to OvercomeThe blood-brain barrier functions as a tightly regulated biological filter, shielding brain tissue from harmful substances traveling through the bloodstream. While this defense mechanism is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers. Research shows that the BBB blocks the passage of most chemical compounds, permitting entry only to certain molecules that meet narrow size and chemistry criteria. The result is that even promising therapeutic candidates often fail to produce meaningful effects simply because they cannot reach the brain in sufficient concentrations.The scale of this problem is striking. Scientific consensus suggests that close to 98% of small-molecule drugs and virtually all biologic therapies are unable to cross the BBB effectively, making this a defining limitation in CNS pharmaceutical development. It also contributes disproportionately to clinical trial failures in neurology, compounds that show real therapeutic promise may nonetheless stumble in trials not because the drug is ineffective, but because it cannot reach its target.The downstream consequences reach across some of the most prevalent and devastating conditions in neurology, from Alzheimer's and Parkinson's disease to primary brain tumors. After decades of intensive research and massive capital investment, effective treatment options for many CNS disorders remain frustratingly scarce. The persistent failure to achieve adequate drug concentrations in the brain has slowed progress across the field, making the search for workable delivery solutions an urgent scientific and commercial priority.Within this context, Oncotelic Therapeutics is developing technologies specifically aimed at getting around these BBB limitations. A concrete marker of progress is the company's recent announcement that it has finalized a strategic monetization agreement with Lunai Bioworks, in which Oncotelic transferred rights to its N2B delivery system for defined applications in biodefense and Alzheimer's disease."Under the terms of the agreement, Oncotelic has granted Lunai Bioworks worldwide rights to the N2B delivery system IP portfolio within defined fields, specifically biodefense medical countermeasures and Alzheimer's disease only," the announcement stated. "The company continues to evaluate additional partnerships to further monetize its portfolio while maintaining strategic control over core assets."By treating delivery infrastructure as a core asset rather than a secondary consideration, Oncotelic is positioning itself within a broader industry move toward integrated solutions that attack the CNS delivery problem head-on.The Growing Weight of Alzheimer's, Neurological DiseaseThe worldwide toll of Alzheimer's disease and other similar forms of dementia is expanding at an alarming pace. According to the World Health Organization, some 57 million people are currently living with dementia globally, a figure projected to grow sharply in the decades ahead as aging populations increase. The human and economic costs of this expansion are substantial, placing mounting pressure on healthcare systems, families, and public finances.Despite this, therapeutic progress has moved slowly. The Alzheimer's Association notes that while researchers have made meaningful strides in understanding the disease at a molecular level, clinical translation has lagged. Drug candidates that look compelling in preclinical settings frequently falter in human trials, often because adequate therapeutic concentrations cannot be sustained within brain tissue, a problem that loops directly back to delivery.New developments across the biopharma landscape highlight both the promise and the stubborn limitations of current approaches. Therapies with demonstrated clinical signals still face ongoing scrutiny over whether effects are consistent and durable, and debates frequently return to the challenge of achieving reliable drug exposure in the brain. These dynamics support the view that delivery remains one of the defining bottlenecks in CNS medicine.Against this backdrop, Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain. By orienting its platform toward targeted and precision delivery, the company is placing itself within a space where solving the delivery problem could substantially improve results across a spectrum of neurodegenerative conditions.Biodefense and the Imperative for Fast CNS InterventionCNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense. Certain chemical and biological threats act directly on the nervous system, and when they do, the window for effective intervention can be extremely narrow. In these high-stakes scenarios, how fast and how effectively a treatment reaches the brain can mean the difference between survival and catastrophic neurological damage.Federal agencies have taken notice. The Biomedical Advanced Research and Development Authority ("BARDA") plays a leading role in funding medical countermeasure development for chemical, biological, radiological, and nuclear threats. Meanwhile, the U.S. Department of Defense has identified CNS injury treatment and neuroprotection as core research areas, a reflection of the operational importance of maintaining neurological function in personnel exposed to hazardous environments.These policy priorities converge on a shared need: Delivery systems that work fast, bypass conventional physiological obstacles, and ensure therapeutics arrive in the brain at concentrations sufficient to produce meaningful effects. When minutes matter, inefficient delivery translates directly into worsened outcomes.Oncotelic Therapeutics is navigating this landscape by exploring applications of its delivery technology that span both commercial medicine and government-funded biodefense programs. This dual-use potential, which is capable of addressing both civilian neurological diseases and emergency response needs, reflects a broader movement toward versatile platforms that can generate value across multiple high-impact markets.Nose-to-Brain Delivery Emerges as a Leading AlternativeWith conventional drug delivery approaches repeatedly running into BBB-related constraints, alternative methods that circumvent the barrier entirely are attracting growing scientific and commercial interest. Among them, intranasal, or "nose-to-brain," delivery has established itself as a particularly compelling option. This pathway leverages anatomical connections between the nasal passages and the brain to transport therapeutic agents directly into CNS tissue, bypassing the bloodstream altogether.Research highlights the capacity of intranasal delivery systems to meaningfully improve drug transport to the brain while keeping systemic exposure low. Evidence from multiple studies indicates that this approach can raise bioavailability and reduce adverse effects—a combination that makes it attractive for long-term use in neurological conditions where patients require sustained treatment.Industry analysis from Deloitte reinforces this trend, noting that CNS therapeutic innovation is shifting its center of gravity from new molecular entities toward delivery technologies. As pharmaceutical and biotech companies seek more consistent clinical outcomes, the ability to get drugs to the right place in the right amounts is increasingly the variable that separates success from failure.Oncotelic's N2B delivery system embodies this philosophy. Designed as a device-enabled approach to direct CNS delivery, it offers a potential alternative to traditional systemic or intramuscular routes. By bypassing the blood-brain barrier, the platform is engineered to accelerate therapeutic onset and improve targeting of the neurological pathways implicated in both acute biodefense emergencies and chronic conditions like Alzheimer's disease.Platform Strategies Are Reshaping CNS InnovationThe trajectory of CNS drug development is moving away from single-asset bets and toward platform-based architectures that can support multiple therapies, indications and commercial pathways. Unlike conventional drug development models, platform approaches offer scalability and adaptability, both qualities particularly suited to an area such as CNS medicine, where diverse conditions often share the same core delivery challenges.Platform-based models allow companies to spread risk across multiple programs while building on a shared technological foundation. By engineering systems that can be configured for different drugs or conditions, developers create multiple routes to revenue while reducing overexposure to any single program's outcome. This structure also aligns naturally with the principles of precision medicine, in which targeted delivery is integral to achieving outcomes that are both effective and patient-specific.For investors, platform strategies carry a distinct appeal. They offer exposure across a range of markets, including neurodegenerative diseases and biodefense, while creating natural opportunities for partnerships, out-licensing, and monetization. This blend of near-term revenue potential with long-term pipeline value is especially compelling in a sector where timelines are long and the risk of any individual asset failing is high.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base. By combining short-term monetization strategies, such as the Lunai Bioworks agreement, with longer-term development opportunities, the company reflects an industry-wide shift toward approaches that address both the scientific complexity and the commercial realities of the CNS space.The challenge of delivering drugs to the brain persists as one of the most consequential barriers in contemporary medicine. With Alzheimer's disease caseloads climbing and national attention focusing on biodefense, the demand for faster and more reliable CNS delivery solutions is intensifying. Meeting that demand will require progress not just in discovering new compounds but in reimagining how those compounds are transported to their targets.Companies working to overcome the blood-brain barrier and enable targeted, efficient brain delivery are staking out positions at the leading edge of a significant shift. Oncotelic Therapeutics is one participant in this broader movement, advancing platform-based approaches designed to expand what is therapeutically possible in CNS medicine. As the field continues to evolve, the capacity to deliver drugs reliably and precisely to the brain may well emerge as the central determinant of future medical progress.Biopharma Innovation Continues Advancing TherapeuticsThe biopharma and advanced therapeutics sector continues to see strong momentum as companies expand research pipelines, pursue strategic partnerships and accelerate development of next-generation treatments targeting complex diseases. Recent announcements across oncology, immunology and precision medicine highlight growing investment in innovative biologics, AI-driven drug discovery, targeted therapies and advanced platform technologies designed to improve outcomes for patients with difficult-to-treat conditions.Amgen Inc. (NASDAQ: AMGN) has acquired Dark Blue Therapeutics, a move that will bolster the company's oncology pipeline and expand its capabilities in targeted protein degradation and leukemia therapeutics. The company noted that acute myeloid leukemia remains one of the most difficult cancers to treat and that the acquisition complements and extends its research in targeted protein degradation and leukemia therapeutics, as well as advances its strategy to invest in novel therapeutic targets and next-generation oncology medicines designed to address difficult-to-treat cancers.Johnson & Johnson (NYSE: JNJ) continues advancing its position in the biopharma and advanced therapeutics space through its Innovative Medicine division, which the company describes as "leading where medicine is going." According to JNJ, patients inform and inspire the company's science-based innovations, which continue to change and save lives with rigorous science and compassion by addressing the most complex diseases and focusing on unlock the medicines of tomorrow. The company's areas of healthcare focus include oncology, immunology, neuroscience and cardiopulmonary.AbbVie Inc. (NYSE: ABBV) has entered an exclusive licensing agreement with RemeGen for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 ("PD-1")/Vascular Endothelial Growth Factor ("VEGF")-targeted bispecific antibody. RC148 is being developed both as a monotherapy and in combination regimens across multiple advanced solid tumors, reinforcing the company's continued expansion in next-generation oncology therapeutics. The agreement reflects AbbVie's strategy to strengthen its oncology pipeline through innovative biologics and advanced immunotherapy approaches targeting difficult cancers.Lunai Bioworks Inc. (NASDAQ: LNAI) announced the launch of an AI oncology pilot with a clinical-stage partner to analyze randomized phase 2 metastatic colorectal cancer survival trial data. The objective of the partnership is to define biologically meaningful patient subgroups that may benefit most from the investigational therapy. Under the pilot agreement, Lunai will deploy its proprietary Augusta AI platform to evaluate de-identified patient-level clinical, imaging, and longitudinal outcomes data, with a focus on overall survival and disease progression endpoints. By integrating traditional clinical variables with AI-derived imaging features and temporal response patterns, Lunai aims to generate data-driven enrichment strategies designed aid in the FDA trial design, including optimized inclusion criteria, endpoint strategy, and its statistical powering.These developments reflect the increasing importance of scientific innovation, data-driven discovery and advanced therapeutic modalities in shaping the future of medicine. As the industry continues evolving toward more personalized, targeted and technology-enabled approaches, companies operating in the space are positioning themselves to play a major role in advancing treatment options across a broad range of serious diseases.For further information about Oncotelic Therapeutics Inc., visit the Oncotelic Therapeutics profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week®May 5, 2026 8:05 AM
PR Newswire (US) AbbVie presents 18 abstracts in Crohn's disease and ulcerative colitis Breadth of data from real-world evidence and clinical trials reinforce risankizumab and upadacitinib efficacy, safety profile, and durability NORTH CHICAGO, Ill., May 5, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI® (risankizumab-rzaa) and RINVOQ® (upadacitinib) in Crohn's disease and ulcerative colitis."As a leader in gastroenterology, AbbVie remains focused on advancing the understanding of IBD and helping raise the standard of care through scientific innovation and a broad portfolio of marketed and investigational therapies," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie. "Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD."Real-World Data for Patients on Risankizumab in Crohn's Disease Sustained symptom relief and reduced need for concomitant therapy: A 52-week follow-up of adults with moderately to severely active Crohn's disease treated with risankizumab from the ASPIRE-CD study showed rapid and sustained improvements in abdominal pain, bowel urgency and liquid/soft stools. Among patients with extraintestinal manifestations of arthritis and skin conditions, 25% and 46%, respectively, reported experiencing relief at Week 52. By Week 52, the use of corticosteroids decreased from 34% at baseline to 7%, and over-the-counter therapies had decreased from 72% at baseline to 49%.Improved quality of life: In an analysis of health-related quality of life (HRQL) and treatment satisfaction after initiating risankizumab in patients enrolled in the ASPIRE-CD study, 77% reported improvement in life enjoyment by Week 52. In addition, patients had improved general wellbeing, including improved sexual health and improved work productivity and daily activity levels one year after starting risankizumab. Overall satisfaction with Crohn's disease treatments improved among all patients (from 50% at baseline to nearly 87% at Week 52), particularly patients who were still being treated with risankizumab at Week 52 (92% satisfaction).Low Switch Rate for Risankizumab Among Crohn's Disease PatientsTreatment persistence: A real-world study of US claims data analyzed the switch rates over a 24-month period among patients with Crohn's disease initiating a new biologic therapy. It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. This pattern was also seen among biologic-naïve patients.Lower Odds of Hospitalization Observed After Switch to UpadacitinibBiologic dose-escalation vs. switching to upadacitinib in a real-world setting: A retrospective analysis of US claims data found that among patients with Crohn's disease or ulcerative colitis treated with a biologic therapy, patients who were switched to upadacitinib had a 31% lower odds of hospitalization and 26% lower odds of emergency department visits than those who increased average weekly dose of the biologic therapy.Endoscopic Improvements in Difficult-to-Treat Crohn's DiseaseTreating patients with Perianal Fistulizing Crohn's disease: Among patients with Perianal Fistulizing Crohn's disease (PFCD), in two Phase 3 trials, those who responded to upadacitinib 45 mg were re-randomized to receive maintenance treatment with upadacitinib (15 mg or 30 mg) or placebo for 52 weeks. In this post-hoc analysis, upadacitinib-treated patients showed endoscopic improvements through 52 weeks, regardless of fistula response, as demonstrated by reductions in Simple Endoscopic Score for Crohn's disease (SES-CD). Majority of these patients were without an adequate response to anti-tumor necrosis factor (TNF) therapy.Select AbbVie abstracts are highlighted below, and all the 2026 DDW Annual Meeting posters are available here:Abstract TitlePresentation NumberReal-World Switching Rates Among Patients with Crohn's Disease
Treated with Biologics in the United StatesSu1657Improvements in Simple Endoscopic Scores for Crohn's Disease in
Upadacitinib-Treated Patients with Perianal Fistulizing Disease:
Post Hoc Analysis of the Phase 3 TrialsSu1495Risankizumab Reduces Crohn's Disease-Related Symptoms and
Concomitant Therapy Use in Adults with Crohn's Disease: Year 1
Results From the ASPIRE-CD StudySa1504Risankizumab Improves Health-Related Quality of Life in Adults
with Crohn's Disease: Year 1 Results from the ASPIRE-CD StudyMo1674Comparative Real-World Outcomes Following Dose Escalation ofCurrent Biologic Therapy Versus Switching to Upadacitinib AmongPatients with Crohn's Disease or Ulcerative Colitis: A Propensity
Score Matched AnalysisTu1655About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.1 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.1 On April 27, 2026, AbbVie announced submission of an application to the FDA seeking approval of SKYRIZI® for subcutaneous induction for the treatment of adult patients with moderately to severely active CD.SKYRIZI®(risankizumab-rzaa) U.S. Uses and Important Safety Information1
SKYRIZI is a prescription medicine used to treat adults with:moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).active psoriatic arthritis.moderate to severe Crohn's disease.moderate to severe ulcerative colitis.IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?SKYRIZI is a prescription medicine that may cause serious side effects, including:
Serious allergic reactions:Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling
lightheaded (low blood pressure)swelling of your face, eyelids, lips,
mouth, tongue, or throat trouble breathing or throat tightnesschest tightnessskin rash, hivesitchingInfections:
SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chillscoughshortness of breathblood in your mucus (phlegm)muscle aches warm, red, or painful skin
or sores on your body
different from your
psoriasisweight loss diarrhea or stomach painburning when you urinate
or urinating more often
than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.Before using SKYRIZI, tell your healthcare provider about all of your medical conditions,
including if you:have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.Use SKYRIZI exactly as your healthcare provider tells you to use it.SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide. About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.Upadacitinib is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. The use of upadacitinib for these diseases is not FDA approved, and its safety and efficacy has not been established for these diseases.RINVOQ ® (upadacitinib) U.S. Uses and Important Safety Information2
RINVOQ is a prescription medicine used to treat:Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.Adults with giant cell arteritis (GCA).Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.RINVOQ/RINVOQ LQ is a prescription medicine used to treat:Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis.IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)
What is the most important information I should know about RINVOQ*?RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or
sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or
urinating more often
than normal Have TB or have been in close contact with someone with TB.Are a current or past smoker.Have had a heart attack, other heart problems, or stroke.Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.Especially tell your HCP if you take: Medicines for fungal or bacterial infectionsRifampicin or phenytoinMedicines that affect your immune systemIf you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.What should I do or tell my HCP AFTER starting RINVOQ?Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes backSevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawPain or discomfort in your arms, back, neck, jaw, or stomachShortness of breath with or without chest discomfortBreaking out in a cold sweatNausea or vomitingFeeling lightheadedWeakness in one part or on one side of your bodySlurred speechTell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: SwellingPain or tenderness in one or both legs Sudden unexplained chest or upper back painShortness of breath or difficulty breathingTell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.These are not all the possible side effects of RINVOQ.How should I take RINVOQ/RINVOQ LQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.Please click here for the Full Prescribing Information and Medication Guide.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=2352835631&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4629860-1%26h%3D3638446932%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fabbvie%252F%26a%3DLinkedIn%252C&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ReferencesSKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026.RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025Global Media:Giovanna Chandler giovanna.chandler@abbvie.comU.S. Media:Stephanie Tennessenstephanie.tennessen@abbvie.comInvestors: Liz Shealiz.shea@abbvie.com View original content:https://www.prnewswire.com/news-releases/abbvie-highlights-new-long-term-data-advancing-treatment-standards-in-inflammatory-bowel-diseases-ibd-at-2026-digestive-disease-week-302761754.htmlSOURCE AbbVie Original: AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week®
US Market News
2月前
AbbVie Reports First-Quarter 2026 Financial ResultsApril 29, 2026 7:47 AM
PR Newswire (US)
Reports First-Quarter Diluted EPS of $0.39 on a GAAP Basis, a Decrease of 45.8 Percent; Adjusted Diluted EPS of $2.65, an Increase of 7.7 Percent; These Results Include an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense
Delivers First-Quarter Net Revenues of $15.002 Billion, an Increase of 12.4 Percent on a Reported Basis or 10.3 Percent on an Operational Basis
First-Quarter Global Net Revenues from the Immunology Portfolio Were $7.290 Billion, an Increase of 16.4 Percent on a Reported Basis, or 14.3 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $4.483 Billion; Global Rinvoq Net Revenues Were $2.119 Billion; Global Humira Net Revenues Were $688 Million
First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.875 Billion, an Increase of 26.0 Percent on a Reported Basis, or 24.3 Percent on an Operational Basis; Global Vraylar Net Revenues Were $905 Million; Global Botox Therapeutic Net Revenues Were $1.009 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $635 Million; Global Vyalev Net Revenues Were $201 Million
First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.631 Billion, a Decrease of 0.2 Percent on a Reported Basis, or 3.0 Percent on an Operational Basis; Global Venclexta Net Revenues Were $770 Million; Global Imbruvica Net Revenues Were $556 Million; Global Elahere Net Revenues Were $198 Million
First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.186 Billion, an Increase of 7.6 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $668 Million; Global Juvederm Net Revenues Were $232 Million
Raises 2026 Adjusted Diluted EPS Guidance Range from $13.96 - $14.16 to $14.08 - $14.28, which Includes an Unfavorable Impact of $0.41 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2026 NORTH CHICAGO, Ill., April 29, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2026."We are off to an excellent start in 2026, with first-quarter results exceeding our expectations. AbbVie's key growth drivers continue to deliver strong performance and support our enhanced full-year outlook," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We are also generating exciting data and advancing numerous programs across all stages of development. Our pipeline progress and solid business fundamentals position AbbVie for robust long-term growth."First-Quarter ResultsWorldwide net revenues were $15.002 billion, an increase of 12.4 percent on a reported basis, or 10.3 percent on an operational basis.Global net revenues from the immunology portfolio were $7.290 billion, an increase of 16.4 percent on a reported basis, or 14.3 percent on an operational basis.Global Skyrizi net revenues were $4.483 billion, an increase of 30.9 percent on a reported basis, or 29.2 percent on an operational basis.Global Rinvoq net revenues were $2.119 billion, an increase of 23.3 percent on a reported basis, or 20.2 percent on an operational basis.Global Humira net revenues were $688 million, a decrease of 38.6 percent on a reported basis, or 40.3 percent on an operational basis.Global net revenues from the neuroscience portfolio were $2.875 billion, an increase of 26.0 percent on a reported basis, or 24.3 percent on an operational basis.Global Vraylar net revenues were $905 million, an increase of 18.4 percent.Global Botox Therapeutic net revenues were $1.009 billion, an increase of 16.5 percent on a reported basis, or 14.9 percent on an operational basis.Global Ubrelvy net revenues were $339 million, an increase of 41.4 percent on a reported basis, or 41.2 percent on an operational basis.Global Qulipta net revenues were $296 million, an increase of 53.6 percent on a reported basis, or 51.3 percent on an operational basis.Global Vyalev net revenues were $201 million.Global net revenues from the oncology portfolio were $1.631 billion, a decrease of 0.2 percent on a reported basis, or 3.0 percent on an operational basis.Global Venclexta net revenues were $770 million, an increase of 15.7 percent on a reported basis, or 9.7 percent on an operational basis.Global Imbruvica net revenues were $556 million, a decrease of 24.7 percent.Global Elahere net revenues were $198 million, an increase of 10.7 percent on a reported basis, or 8.3 percent on an operational basis.Global net revenues from the aesthetics portfolio were $1.186 billion, an increase of 7.6 percent on a reported basis, or 5.1 percent on an operational basis.Global Botox Cosmetic net revenues were $668 million, an increase of 20.2 percent on a reported basis, or 17.0 percent on an operational basis.Global Juvederm net revenues were $232 million, an increase of 0.4 percent on a reported basis, or a decrease of 2.9 percent on an operational basis.On a GAAP basis, the gross margin ratio in the first quarter was 71.9 percent. The adjusted gross margin ratio was 83.6 percent.
On a GAAP basis, selling, general and administrative (SG&A) expense was 23.9 percent of net revenues. The adjusted SG&A expense was 22.7 percent of net revenues.
On a GAAP basis, research and development (R&D) expense was 16.5 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues.
Acquired IPR&D and milestones expense was 5.0 percent of net revenues.
On a GAAP basis, the operating margin ratio in the first quarter was 26.6 percent. The adjusted operating margin ratio was 40.8 percent.
Net interest expense was $645 million.
On a GAAP basis, the tax rate in the quarter was 32.9 percent. The adjusted tax rate was 15.4 percent.
Diluted earnings per share (EPS) in the first quarter was $0.39 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense.Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.Recent EventsAbbVie announced it submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Skyrizi (risankizumab) for subcutaneous (SC) induction in the treatment of adult patients with moderately to severely active Crohn's disease (CD). AbbVie expects an approval decision later this year, which would offer adult CD patients an additional option for induction of Skyrizi. The submission is supported by data from the Phase 3 AFFIRM study evaluating the efficacy and safety of Skyrizi SC induction in adult patients with moderately to severely active CD. In the study, Skyrizi achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by SC injection versus placebo. The safety profile of Skyrizi SC induction was consistent with its known profile in CD, with no new safety risks observed.
AbbVie announced it submitted an application to the FDA for a new indication for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients with severe alopecia areata (AA). The submission is supported by data from the Phase 3 UP-AA clinical program in which Rinvoq achieved the primary endpoint as well as key secondary endpoints.
At the 2026 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented key data reinforcing the company's leadership in advancing standards of care across immune-mediated skin diseases. Presentations showcased the efficacy and safety of Skyrizi in psoriatic disease, real-world evidence of minimal disease activity and clinical long-term safety outcomes of Rinvoq in atopic dermatitis (AD), as well as Phase 3 data for Rinvoq in vitiligo and AA. The company also presented data highlighting the safety and efficacy of new and emerging products in AbbVie's aesthetics portfolio, including trenibotulinumtoxinE.
AbbVie announced the FDA approved a supplemental new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). This approval establishes the Venclexta and acalabrutinib combination as the first all-oral, fixed-duration regimen for previously untreated CLL, offering patients the potential of time off treatment. The approval is supported by data from the Phase 3 AMPLIFY trial.
At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie presented Phase 2 data for Elahere in platinum-sensitive ovarian cancer (PSOC). Results from the IMGN853-0420 trial showed a more than 60 percent objective response rate (ORR) and consistent safety findings with Elahere plus carboplatin followed by a continuation of Elahere monotherapy in patients with folate receptor alpha (FRa)-expressing PSOC. These findings highlight Elahere's potential expanding role across the ovarian cancer treatment continuum.
AbbVie announced it received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (trenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for trenibotE and does not request additional clinical studies. AbbVie is confident that it can address the FDA's comments promptly and expects to submit a thorough response in the coming months.
AbbVie announced positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. In the study, ABBV-295 treatment showed clinically meaningful body weight reduction at week 12 (weekly dosing) and week 13 (every other week and monthly dosing after week 5). ABBV-295 also demonstrated a favorable tolerability profile at all evaluated dose levels, with no serious adverse events reported. Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action.
AbbVie announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines.AbbVie announced a $380 million investment to build two new active pharmaceutical ingredient (API) manufacturing facilities at its North Chicago, Illinois, campus. These state-of-the-art facilities will integrate advanced manufacturing technologies with AI to support the production of AbbVie's next-generation neuroscience and obesity medications.
AbbVie announced the opening of the Allergan Medical Institute (AMI) Training Center in Austin, Texas. This location marks the third U.S. AMI Training Center opened in the last year, reflecting AbbVie's continued investment in aesthetics training and education.Full-Year 2026 OutlookAbbVie is raising its adjusted diluted EPS guidance for the full year 2026 from $13.96 - $14.16 to $14.08 - $14.28, which includes an unfavorable impact of $0.41 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2026. The company's 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2026, as both cannot be reliably forecasted.About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3584363904&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Conference CallAbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time.Non-GAAP Financial ResultsFinancial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.Media:Investors:
Gabby TarbertLiz Shea
(224) 244-0111(847) 935-2211
Todd Bosse
(847) 936-1182
Jeffrey Byrne
(847) 938-2923
AbbVie Inc.Key Product RevenuesQuarter Ended March 31, 2026(Unaudited)
% Change vs. 1Q25
Net Revenues (in millions)
Reported
Operationala
U.S.
Int'l.
Total
U.S.
Int'l.
Total
Int'l.
TotalNET REVENUES$10,969
$4,033
$15,002
9.9 %
19.9 %
12.4 %
11.4 %
10.3 %
Immunology5,537
1,753
7,290
13.4
26.9
16.4
17.3
14.3Skyrizi3,775
708
4,483
29.3
39.8
30.9
28.0
29.2Rinvoq1,405
714
2,119
15.1
43.4
23.3
32.6
20.2Humira357
331
688
(52.0)
(12.3)
(38.6)
(17.4)
(40.3)
Neuroscience2,459
416
2,875
24.7
34.4
26.0
21.8
24.3Vraylar902
3
905
18.2
67.6
18.4
58.9
18.4Botox Therapeutic842
167
1,009
16.5
16.3
16.5
6.7
14.9Ubrelvy330
9
339
41.7
29.2
41.4
22.9
41.2Qulipta250
46
296
45.4
>100.0
53.6
99.7
51.3Vyalev89
112
201
>100.0
98.3
>100.0
76.9
>100.0Other Neuroscience 46
79
125
(38.9)
(1.5)
(19.6)
(11.7)
(24.8)
Oncology882
749
1,631
(14.1)
23.4
(0.2)
15.7
(3.0)Venclexta341
429
770
9.2
21.4
15.7
10.1
9.7Imbruvicab332
224
556
(37.4)
7.2
(24.7)
7.2
(24.7)Elahere160
38
198
(2.9)
>100.0
10.7
>100.0
8.3Epkinlyc25
58
83
22.1
89.3
62.0
81.8
57.6Other Oncology24
—
24
n/m
n/m
n/m
n/m
n/m
Aesthetics704
482
1,186
9.8
4.5
7.6
(1.5)
5.1Botox Cosmetic371
297
668
25.8
13.9
20.2
7.1
17.0Juvederm Collection85
147
232
12.2
(5.3)
0.4
(10.3)
(2.9)Other Aesthetics248
38
286
(8.4)
(15.7)
(9.4)
(20.5)
(10.1)
Other Key Products816
179
995
28.5
3.0
23.0
(7.9)
20.7Mavyret183
168
351
28.3
2.4
14.5
(8.6)
8.6Creon361
—
361
1.8
n/m
1.8
n/m
1.8Linzess272
11
283
96.9
12.7
91.5
3.0
90.9
a "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.b Reflects profit sharing for Imbruvica international revenues.c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories.n/m = not meaningful AbbVie Inc.Consolidated Statements of Earnings (Unaudited)
(in millions, except per share data) First QuarterEnded March 31
2026
2025Net revenues$ 15,002
$ 13,343Cost of products sold4,218
4,002Selling, general and administrative3,578
3,293Research and development2,472
2,067Acquired IPR&D and milestones744
248Total operating costs and expenses11,012
9,610
Operating earnings3,990
3,733
Interest expense, net645
627Other expense, net2,306
1,445Earnings before income tax expense1,039
1,661Income tax expense342
372Net earnings697
1,289Net earnings attributable to noncontrolling interest 2
3Net earnings attributable to AbbVie Inc.$ 695
$ 1,286
Diluted earnings per share attributable to AbbVie Inc.$ 0.39
$ 0.72
Adjusted diluted earnings per sharea$ 2.65
$ 2.46
Weighted-average diluted shares outstanding1,774
1,772
a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. AbbVie Inc.Reconciliation of GAAP Reported to Non-GAAP Adjusted Information(Unaudited)
1. Specified items impacted results as follows:
Quarter Ended March 31, 2026(in millions, except per share data)Earnings
Diluted
Pre-tax
After-taxa
EPSAs reported (GAAP)$ 1,039
$ 695
$ 0.39Adjusted for specified items:
Intangible asset amortization1,748
1,498
0.85Change in fair value of contingent consideration 2,387
2,325
1.31Other395
193
0.10As adjusted (non-GAAP)$ 5,569
$ 4,711
$ 2.65
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2026 included acquired IPR&D and milestones expense of $744
million on a pre-tax and $738 million on an after-tax basis, representing an unfavorable impact of $0.41 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Quarter Ended March 31, 2026(in millions)Cost of
products
sold
SG&A
R&D
Other
expense,
netAs reported (GAAP)$ 4,218
$ 3,578
$ 2,472
$ 2,306Adjusted for specified items:
Intangible asset amortization(1,748)
—
—
—Change in fair value of contingent consideration —
—
—
(2,387)Other(8)
(177)
(204)
(6)As adjusted (non-GAAP)$ 2,462
$ 3,401
$ 2,268
$ (87)
3. The adjusted tax rate for the first quarter of 2026 was 15.4 percent, as detailed below:
Quarter Ended March 31, 2026(dollars in millions)Pre-tax
earnings
Income taxes
Tax rateAs reported (GAAP)$ 1,039
$ 342
32.9 %Specified items4,530
514
11.3 %As adjusted (non-GAAP) $ 5,569
$ 856
15.4 % AbbVie Inc.Reconciliation of GAAP Reported to Non-GAAP Adjusted Information(Unaudited)
1. Specified items impacted results as follows:
Quarter Ended March 31, 2025(in millions, except per share data)Earnings
Diluted
Pre-tax
After-taxa
EPSAs reported (GAAP)$ 1,661
$ 1,286
$ 0.72Adjusted for specified items:
Intangible asset amortization1,858
1,574
0.89Change in fair value of contingent consideration 1,518
1,477
0.83Other62
33
0.02As adjusted (non-GAAP)$ 5,099
$ 4,370
$ 2.46
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates.
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2025 included acquired IPR&D and milestones expense of $248
million on a pre-tax and $238 million on an after-tax basis, representing an unfavorable impact of $0.13 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows:
Quarter Ended March 31, 2025(in millions)Cost of
products
sold
SG&A
R&D
Other
expense,
netAs reported (GAAP)$ 4,002
$ 3,293
$ 2,067
$ 1,445Adjusted for specified items:
Intangible asset amortization(1,858)
—
—
—Change in fair value of contingent consideration —
—
—
(1,518)Other(28)
(13)
(16)
(5)As adjusted (non-GAAP)$ 2,116
$ 3,280
$ 2,051
$ (78)
3. The adjusted tax rate for the first quarter of 2025 was 14.2 percent, as detailed below:
Quarter Ended March 31, 2025(dollars in millions)Pre-tax
earnings
Income taxes
Tax rateAs reported (GAAP)$ 1,661
$ 372
22.4 %Specified items3,438
354
10.3 %As adjusted (non-GAAP) $ 5,099
$ 726
14.2 %
View original content:https://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2026-financial-results-302757172.htmlSOURCE AbbVie
Original: AbbVie Reports First-Quarter 2026 Financial Results
US Market News
2月前
AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's DiseaseApril 27, 2026 8:05 AM
PR Newswire (US)
Submission supported by data from Phase 3 pivotal AFFIRM study If approved, adult Crohn's disease patients will have an additional option for induction of risankizumab-rzaa which is already approved for intravenous (IV) inductionNORTH CHICAGO, Ill., April 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for SKYRIZI® (risankizumab-rzaa) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD)."Crohn's disease is a chronic inflammatory condition that affects an estimated 1 million Americans, and its impact often reaches beyond the gut as its unpredictability can impact daily life and emotional health for patients," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "AbbVie continues to invest in research and innovative solutions to help elevate the standard of care for patients so that they may live a life unburdened by their Crohn's disease."The application to the FDA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, including both those with and without prior advanced therapy failure.In 2022, SKYRIZI became the first interleukin-23 (IL-23) specific inhibitor approved by the FDA to treat adults with moderately to severely active CD. AbbVie anticipates FDA approval for this new dosing regimen for SKYRIZI later this year. If approved, patients with moderately to severely active CD would have a choice to receive their SKYRIZI induction via SC injection or through IV infusion and then continue subcutaneous maintenance dosing every eight weeks.About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.2,3 It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.4,5 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically but also emotionally and economically.6About the AFFIRM Study1
AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were achievement of CDAI Clinical Remission (CDAI < 150) and achievement of endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups; 65% had previously failed advanced therapies for the treatment of CD. The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.1 More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).7About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.8 SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.8,9U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)8
SKYRIZI is a prescription medicine used to treat adults with:moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).active psoriatic arthritis.moderate to severe Crohn's disease.moderate to severe ulcerative colitis.IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?SKYRIZI is a prescription medicine that may cause serious side effects, including:
Serious allergic reactions:Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded
(low blood pressure)swelling of your face, eyelids, lips,
mouth, tongue, or throat trouble breathing or throat tightnesschest tightnessskin rash, hivesitchingInfections:
SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chillscoughshortness of breathblood in your mucus (phlegm)muscle aches warm, red, or painful skin
or sores on your body
different from your psoriasisweight loss diarrhea or stomach painburning when you urinate
or urinating more often
than normalDo not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.Use SKYRIZI exactly as your healthcare provider tells you to use it.SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.This is the most important information to know about SKYRIZI. For more information, talk to your HCP.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide.Globally, prescribing information varies; refer to the individual country product label for complete information.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=1431542392&u=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4629860-1%26h%3D3638446932%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fabbvie%252F%26a%3DLinkedIn%252C&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ReferencesAbbVie. Data on file ABVRRTI82775Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed February 23, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdfMayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic. Accessed February 23, 2026. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.Gajendran M, et al. A comprehensive review and update on Crohn's disease. Dis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06063967. Accessed February 23, 2026.SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025.SKYRIZI. Summary of Product Characteristics. AbbVie. Accessed February 23, 2026.U.S. Media: Investors:Stephanie Tennessen Liz SheaStephanie.tennessen@abbvie.com liz.shea@abbvie.com
Global Media:
Giovanna Chandler
giovanna.chandler@abbvie.com
View original content:https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-skyrizi-risankizumab-rzaa-subcutaneous-induction-for-adults-with-moderately-to-severely-active-crohns-disease-302753553.htmlSOURCE AbbVie
Original: AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease
US Market News
3月前
Erin Lichy Gets Real About Her Natrelle® Breast AugmentationApril 14, 2026 8:50 AM
PR Newswire (US)
The entrepreneur and mother of four shares her breast augmentation journey, from consultation to post-op, with Natrelle® breast implants. As a champion of authenticity, Lichy hopes her transparency will help normalize the conversation around breast surgery.IRVINE, Calif., April 14, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV) has teamed up with New York-based entrepreneur and television personality, Erin Lichy. Lichy is opening up about her recent breast augmentation with market-leading Natrelle® breast implants in an effort to promote transparency and normalize conversations around aesthetic procedures. As a mom of four, and after years of breastfeeding, Lichy's decision to pursue breast augmentation is a part of her personal journey towards renewed body positivity. By sharing her story, Lichy aims to support other women considering breast surgery.
"Motherhood and breastfeeding changed my body in ways I didn't fully expect, and I found myself wanting to feel more like me again," said Erin Lichy. "I didn't originally consider breast implants because I was looking for an understated result, but after sharing my aesthetic goals with board-certified plastic surgeon Dr. Ira Savetsky, we chose Natrelle® implants. It was a very educational conversation. We talked about projection, profile, the safety of the implant and how they would look on my body. I'm thrilled with my results, and I'm sharing my experience to help other women feel more confident to explore their own options."As part of her partnership with Natrelle®, Lichy will be sharing her experience from consultation to post-op across her social media channels."Every woman's aesthetic journey is unique. Erin's transparency and willingness to share her story fosters connection for other women," said Nicole Mowad-Nassar, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Honest conversations are the first step in helping women who may be interested in breast augmentation feel empowered to schedule a consultation and learn more."With the most comprehensive range of smooth breast implant options, Natrelle® is built on a 50-year legacy of innovation in breast aesthetics and offers five profiles and three gummy gel cohesivities1, giving board-certified plastic surgeons the flexibility to tailor each patient's desired results. Natrelle® breast implants have a 10-year clinical safety profile backed by a rigorous clinical trial.1 As more women seek clear, credible information about aesthetic procedures, Natrelle® continues to prioritize patient education and close partnership with board-certified plastic surgeons.1Patients who are inspired by Erin's story can continue fueling the transparent conversation by entering the Faces of Natrelle® Testimonial Program. The nationwide initiative invites women who have undergone breast augmentation or reconstruction with Natrelle® implants to share their personal experiences through photos, videos, and written testimonials for a chance to be featured on the brand's social media platforms, and website.To learn more about eligibility and how to submit your story, visit:Augmentation Patients: faces.natrelle.com/augmentationReconstruction Patients: faces.natrelle.com/reconstructionTo learn more about treatment with Natrelle® or find a provider, please visit natrelle.com, and follow along on Instagram @natrellebreastaugmentation and @natrellebreastreconstruction.Natrelle®?Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth?implants, although rates are not well defined. Some patients have died from BIA-ALCL. Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement. Who can get breast implants?
Natrelle®?Breast Implants are approved for the following: Breast augmentation?for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants.?Breast augmentation includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation Breast reconstruction.?This includes primary breast reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. This also includes revision surgery to correct or improve the result of a primary breast reconstruction Who should NOT get breast implants?
Breast implant surgery should NOT be performed in: Women with active infection anywhere in their body Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions Women who are currently pregnant or nursing What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: Autoimmune diseases (eg, lupus and scleroderma) A weakened immune system (eg, taking medications to decrease the body's immune response) Planned chemotherapy or radiation therapy following breast implant placement Conditions or medications that interfere with wound healing and blood clotting Reduced blood supply to breast tissue Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders Those with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery What else should I consider? There is a Boxed Warning for breast implants. Please see bold text at beginning Many changes to your breasts following implantation are irreversible. If you later choose to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent Breast implantation is likely not a one-time surgery. The longer implants are in place, the greater the potential risk for complications. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Thus, you should also consider the complication rates for later (revision) surgery since you may experience these risks in the future Cancer treatments and surgery will affect the outcome and timing of breast reconstruction Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production Rupture of a silicone-filled breast implant is most often silent. Even if you have no symptoms, you should have your first ultrasound or MRI at 5 to 6 years after your initial implant surgery and then every 2 to 3 years thereafter regardless of whether your implants are for augmentation or reconstruction.?If you have symptoms of or uncertain ultrasound results for breast implant rupture, an MRI is recommended. Additional imaging may be required depending on your medical history and status. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established Routine screening mammography for breast cancer will be more difficult, and implants may rupture during the procedure. Perform self-examination every month for cancer screening and ask your surgeon to help you distinguish the implant from your breast tissue. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging What are key complications with breast implants?
Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility. Talk to your doctor about other complications. For more information, see the patient brochures at https://www.rxabbvie.com.To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261. The sale and distribution of?Natrelle®?Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery. About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit?www.allerganaesthetics.com. About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=790178173&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.References: Natrelle® Data on file 2023 – 2024. Accessed April 10, 2026.© 2026 AbbVie. All rights reserved. NATRELLE and its design are trademarks of Allergan, Inc., an AbbVie company.Contacts: Allergan Aesthetics Media:
Ember Garrett
+1 (949) 413-6091
Garrett_ember@allergan.com?AbbVie Investors:
Liz Shea
+1 (847) 935-2211
Liz.Shea@abbvie.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/erin-lichy-gets-real-about-her-natrelle-breast-augmentation-302741658.htmlSOURCE AbbVie
Original: Erin Lichy Gets Real About Her Natrelle® Breast Augmentation
US Market News
3月前
AbbVie Showcases Late-Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum-Sensitive Ovarian Cancer (PSOC) at SGO 2026April 12, 2026 7:15 AM
PR Newswire (US)
Results from the Phase 2 IMGN853-0420 trial show an objective response rate of 62.7% and consistent safety findings with mirvetuximab soravtansine-gynx (ELAHERE®) plus carboplatin followed by a continuation of mirvetuximab soravtansine monotherapy in patients with ≥50 % folate receptor alpha (FRa)-expressing, platinum-sensitive ovarian cancer (PSOC).Findings highlight mirvetuximab soravtansine's potential across the ovarian cancer treatment continuum. Data is being presented in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting. NORTH CHICAGO, Ill., April 12, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that late-breaking results from the Phase 2 IMGN853-0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting (San Juan, Puerto Rico; April 10-13, 2026). The study evaluated the potential efficacy and safety of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC), in combination with carboplatin followed by maintenance of mirvetuximab soravtansine-gynx monotherapy, in patients with folate receptor alpha (FRa)-expressing, recurrent platinum-sensitive ovarian cancer (PSOC).The multicenter, open-label study enrolled 125 patients with FRa-positive, measurable disease who had received one prior platinum-based chemotherapy regimen. Participants received mirvetuximab soravtansine-gynx plus carboplatin every three weeks for six to eight cycles, followed by single-agent mirvetuximab soravtansine-gynx as a continuation therapy. Nearly half of patients had prior exposure to a polymerase inhibitor (PARPi), a patient population who may experience reduced responses to subsequent platinum-based chemotherapy.1The primary endpoint of the study was a confirmed objective response rate (ORR) in the ≥50% FRa subgroup after six cycles of combination therapy.2 Key secondary endpoint was ORR after six cycles in the overall population (FRa ≥25%) and additional secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS). "Despite being considered chemotherapy-responsive, platinum-sensitive ovarian cancer (PSOC) remains challenging to treat. With each recurrence, responses to standard platinum-based chemotherapy often diminish and patients may experience cumulative toxicities,"3 said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results are encouraging and further support the potential of mirvetuximab soravtansine-gynx in PSOC as a novel treatment regimen."Key highlights from the late-breaking oral presentation include: Response rates across combination regimen: By the end of the induction phase, confirmed ORR was 62.7% (95% CI, 52.6–72.1) in the FRa ≥50% subgroup and 62.4% (95% CI, 53.3–70.9) in the overall population. 81% of patients (101/125) showed no disease progression and continued treatment with single-agent mirvetuximab soravtansine.2 Median DoR was 11.2 months across the overall population.2Additional responses with continuation monotherapy: Among patients who were on the combination and transitioned to mirvetuximab soravtansine-gynx monotherapy, ORR was 68% (59.1–76.1) across the overall population.2 Responses in patients with prior exposure to polymerase inhibitor (PARPi): In nearly half of patients (49%) in the overall population (FRa ≥25%) who had prior PARPi exposure, ORR was 63.9% (50.6–75.8).2Safety data: The safety profile of mirvetuximab soravtansine-gynx was consistent with findings from previous studies. The most common treatment-related adverse events (TRAEs) with mirvetuximab soravtansine-gynx plus carboplatin followed by a continuation of mirvetuximab-soravtansine-gynx alone were low-grade ocular events, including corneal changes that were reversible in over 90% of patients.2 The most common grade ≥3 TRAEs (>5%) were neutropenia (15%), blurred vision (10%), thrombocytopenia (10%), cataract (6%), dry eye (5%), diarrhea (5%) and peripheral sensory neuropathy (5%).2"The combination of mirvetuximab soravtansine-gynx and carboplatin delivered strong responses in this Phase 2 study and many patients continued to experience responses during the monotherapy treatment phase," said Gottfried E. Konecny, M.D., Professor of Medicine, David Geffen School of Medicine at UCLA, and primary investigator. "These findings support further investigation of a novel treatment approach that integrates antibody drug conjugates with standard chemotherapy in patients with folate receptor alpha (FRa)-expressing recurrent platinum-sensitive ovarian cancer and in patients previously treated with PARP inhibitors who often face resistance and remain in need of additional options."The data is being presented during the Rapid-Fire Oral III: Translational and ADC session on Sunday, April 12 at 12:32 PM ET. More information about the 2026 SGO Annual Meeting and abstracts being presented are available here. Further information on AbbVie clinical trials is also available at https://clinicaltrials.gov/. Use of mirvetuximab soravtansine-gynx plus carboplatin followed by mirvetuximab soravtansine-gynx continuation in FRa-expressing recurrent PSOC is not approved in the U.S. or in the E.U. or in any other territory. The safety and efficacy of mirvetuximab soravtansine-gynx for use as a combination therapy in PSOC have not been established.About the IMGN853-0420 Trial
IMGN853-0420 (NCT05456685) is a multicenter, open-label, single-arm Phase 2 study evaluating the efficacy and safety of carboplatin plus mirvetuximab soravtansine-gynx followed by mirvetuximab soravtansine-gynx continuation in folate receptor-alpha (FRa) positive (≥25% tumor cells with ≥2+ membrane intensity), recurrent platinum-sensitive high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following one prior line of platinum-based chemotherapy. After completing six cycles of mirvetuximab soravtansine-gynx plus carboplatin, participants without progressive disease continue on single-agent mirvetuximab soravtansine-gynx. Eligibility requires confirmed FRa positivity using the Ventana FOLR1 Assay, ensuring enrollment of participants most likely to benefit from this FRa-targeted ADC approach.About ELAHERE®
ELAHERE® (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE® is currently indicated for the treatment of adult patients with folate receptor-alpha (FRa) positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. It is being investigated in patients with platinum-sensitive ovarian cancer.ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATIONWhat is ELAHERE?ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:have not responded to or are no longer responding to treatment with platinum-based chemotherapy andhave received 1 to 3 prior types of chemotherapy.Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about ELAHERE?ELAHERE can cause serious side effects, including:Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.What should I tell my healthcare provider before receiving ELAHERE?Tell your healthcare provider about all of your medical conditions, including if you:have vision or eye problems.have numbness or tingling in your hands or feet.have liver problems.are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Patients who are able to become pregnant:Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.What are the possible side effects of ELAHERE?ELAHERE can cause serious side effects, including:Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.The most common side effects and abnormal labs of ELAHERE include: increased liver enzymes in the bloodfeeling tiredblurred visionnauseadiarrhea stomach-area (abdominal) painchanges in the cornea (part of the eye)peripheral neuropathymuscle, bone, or joint pain decreased red or white blood cell counts decreased plateletsdecreased magnesium level in the blooddry eyeconstipationvomitingdecreased albumin level in the blooddecreased appetiteYour healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.Please see Full Prescribing Information, including Boxed WARNING and Medication Guide.About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ReferencesMacAulay Vacheresse, Genevieve, et al. "Response to Subsequent Platinum-Based Chemotherapy Post PARP Inhibitor in Recurrent Epithelial Ovarian Cancer." Journal of Clinical Oncology, vol. 41, no. 16 suppl., 2023. Abstract 5578 presented at the American Society of Clinical Oncology Annual Meeting. Chicago, IllinoisKonecny, Gottfried E., et al. "Mirvetuximab soravtansine plus carboplatin in folate receptor alpha-expressing recurrent platinum-sensitive ovarian cancer." Abstract presented at the Society of Gynecologic Oncology Annual Meeting, 2026. San Juan, Puerto RicoRichardson DL, Eskander RN, O'Malley DM. Advances in Ovarian Cancer Care and Unmet Treatment Needs for Patients With Platinum Resistance: A Narrative Review. JAMA Oncol. 2023;9(6):851–859. doi:10.1001/jamaoncol.2023.0197Contacts:
Media:Investors: Mabel Martinez Liz Sheamabel.martinez@abbvie.comliz.shea@abbvie.com
View original content:https://www.prnewswire.com/news-releases/abbvie-showcases-latebreaking-phase-2-data-for-mirvetuximab-soravtansine-gynx-elahere-in-platinumsensitive-ovarian-cancer-psoc-at-sgo-2026-302739847.htmlSOURCE AbbVie
Original: AbbVie Showcases Late-Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (ELAHERE®) in Platinum-Sensitive Ovarian Cancer (PSOC) at SGO 2026
US Market News
3月前
/C O R R E C T I O N -- AbbVie/March 31, 2026 10:04 AM
PR Newswire (US)
In the news release, Allergan Aesthetics Announces Fourth Annual, All-Access CoolMonth with Deals on CoolSculpting®, issued 31-Mar-2026 by AbbVie over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end:
Allergan Aesthetics Announces Fourth Annual, All-Access CoolMonth with Deals on CoolSculpting®
First-Time Users Can Claim $400 Off Their First Body Contouring Treatment.*†IRVINE, Calif., March 31, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced its fourth annual CoolMonth, featuring exclusive offers on CoolSculpting®, the treatment doctors use most for nonsurgical fat reduction.1
Spring is often thought of as a transformative season, making the return of CoolMonth this April a perfect opportunity to reprioritize aesthetic goals. In fact, 50% of people reportedly have considered body contouring treatments (invasive and noninvasive) in preparation for summer.2‡CoolSculpting® can permanently eliminate treated fat without surgery and with little to no downtime.3,4 It is an FDA-cleared product proven to contour the body by freezing away stubborn fat.5 "By establishing this meaningful annual moment, we're not only translating interest into action—we're building trust and advancing education," said Glen Curran, Senior Vice President Allergan Aesthetics. "Whether patients are experiencing body changes following weight loss with GLP-1 medication, noticing specific areas resistant to diet and exercise, or simply seeking a more sculpted appearance, CoolMonth helps them take the next step toward achieving their goals."Follow these steps to access CoolMonth offers:Join Alle, the Allergan Aesthetics Loyalty Program: If you're not already a member, visit Alle to register for free and take advantage of offers year-round.Redeem the CoolMonth First-Time Patients Promotion: New patients can claim $400 off their first CoolSculpting® treatment starting April 1 through April 30, 2026 (while supplies last)*†. See if you are eligible for the limited-time CoolMonth offer at https://coolscul.pt/new-patients.Enter for a Chance to Win Exciting Giveaways: Follow @CoolSculpting on Instagram and be on the lookout for the chance to win exciting giveaways, including up to $5,000 worth of CoolSculpting®*."The spring is a great time to begin a personalized CoolSculpting® treatment plan so you can start seeing results in time for warmer weather," said Melissa Mickelson, Co-Founder Bodify and Master Certified CoolSculpting® Expert. Jessica Stellwagen, Co-Founder Bodify and Master Certified CoolSculpting® Expert, continued saying, "During each consultation, we evaluate whether a patient is a good candidate, discuss their body contouring goals, and create a customized approach to help achieve their desired look. If you've been considering body contouring, CoolMonth is the perfect time to take advantage of this special offer and book your consultation."CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.To learn more about CoolSculpting® and CoolSculpting® Elite, the CoolMonth offerings and to find a provider near you, please visit www.CoolSculpting.com.*NO PURCHASE NECESSARY. Open to Alle Members in 50 U.S./D.C.; 18+ (19+ in AL, NE; 21+ in MS). You must register online at https://coolscul.pt/new-patients between 12:00:01 AM PT on 4/1/26 and 11:59:59 PM PT on 4/30/26. See full Official Rules for all details and how to enter without purchase at https://coolscul.pt/new-patients.†Offers are for a limited time only and while supplies last. Terms and Conditions apply. Limited Member eligibility applies.‡Online survey conducted in 2023 of consumers aged between 25 to 55 with a household income of > $75,000 (N= 200 consumers aware of and interested in receiving body contouring within the next year)About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.comAbout AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3994416478&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.CoolSculpting® and CoolSculpting® Elite Uses and Important Safety InformationUsesCoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.Important Safety InformationThis procedure is not for everyone. You should not be treated with CoolSculpting® or CoolSculpting® Elite if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.Tell your doctor if you are pregnant or have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, cramping and discomfort at the treatment site. These sensations lessen as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, stinging, tenderness, cramping, skin inflammation and aching. Sensory alteration (itching, skin sensitivity, tingling, and numbness) can persist up to several weeks after treatment. You may also experience throat discomfort/soreness and sensation of fullness in the back of the throat after submental or submandibular area treatment.Rare side effects may happen in 1 to 10 out of 10,000 CoolSculpting® and CoolSculpting® Elite treatments (between 0.01% to 0.1%). One such rare side effect is a visible enlargement in the treated area, which may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.Please see full Important Safety Information for CoolSculpting® and CoolSculpting® Elite on CoolSculpting.com.REFERENCES:Data on file, Allergan, 2025; Portfolio Aesthetic Monthly Tracker; August 2025 Data Month.Data on file, Allergan, March 2023; Sizing Allergan® Attitude & Agreement on Body Contouring Journey (NIBC) Study.Stevens WG, Eagan MM, Felber C, Sarhaddi D, Orlando MV. Cryolipolysis. In: Few JW Jr, ed. The Art of Combining Surgical and Nonsurgical Techniques in Aesthetic Medicine. Thieme; 2018:132-149.Avram MM, Harry RS. Cryolipolysis™ for subcutaneous fat layer reduction. Lasers in Surgery and Medicine 2009 Dec;41(10):703-8.Zeltiq Aesthetics. User Manual CoolSculpting® Elite System CS-UM- CM3-02-EN-K. 2024.Investors:
Liz Shea
Liz.Shea @arkieboyMedia:
Ember Garrett
Ember.Garrett @was Zeus Correction: Links in the *NO PURCHASE NECESSARY. paragraph have been updated from an earlier version of this release.
View original content to download multimedia:https://www.prnewswire.com/news-releases/allergan-aesthetics-announces-fourth-annual-all-access-coolmonth-with-deals-on-coolsculpting-302729041.htmlSOURCE AbbVie
Original: /C O R R E C T I O N -- AbbVie/
US Market News
3月前
Allergan Aesthetics Announces Fourth Annual, All-Access CoolMonth with Deals on CoolSculpting®March 31, 2026 8:05 AM
PR Newswire (US)
First-Time Users Can Claim $400 Off Their First Body Contouring Treatment.*†IRVINE, Calif., March 31, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced its fourth annual CoolMonth, featuring exclusive offers on CoolSculpting®, the treatment doctors use most for nonsurgical fat reduction.1
Spring is often thought of as a transformative season, making the return of CoolMonth this April a perfect opportunity to reprioritize aesthetic goals. In fact, 50% of people reportedly have considered body contouring treatments (invasive and noninvasive) in preparation for summer.2‡CoolSculpting® can permanently eliminate treated fat without surgery and with little to no downtime.3,4 It is an FDA-cleared product proven to contour the body by freezing away stubborn fat.5 "By establishing this meaningful annual moment, we're not only translating interest into action—we're building trust and advancing education," said Glen Curran, Senior Vice President Allergan Aesthetics. "Whether patients are experiencing body changes following weight loss with GLP-1 medication, noticing specific areas resistant to diet and exercise, or simply seeking a more sculpted appearance, CoolMonth helps them take the next step toward achieving their goals."Follow these steps to access CoolMonth offers:Join Alle, the Allergan Aesthetics Loyalty Program: If you're not already a member, visit Alle to register for free and take advantage of offers year-round.Redeem the CoolMonth First-Time Patients Promotion: New patients can claim $400 off their first CoolSculpting® treatment starting April 1 through April 30, 2026 (while supplies last)*†. See if you are eligible for the limited-time CoolMonth offer at https://coolscul.pt/new-patients.Enter for a Chance to Win Exciting Giveaways: Follow @CoolSculpting on Instagram and be on the lookout for the chance to win exciting giveaways, including up to $5,000 worth of CoolSculpting®*."The spring is a great time to begin a personalized CoolSculpting® treatment plan so you can start seeing results in time for warmer weather," said Melissa Mickelson, Co-Founder Bodify and Master Certified CoolSculpting® Expert. Jessica Stellwagen, Co-Founder Bodify and Master Certified CoolSculpting® Expert, continued saying, "During each consultation, we evaluate whether a patient is a good candidate, discuss their body contouring goals, and create a customized approach to help achieve their desired look. If you've been considering body contouring, CoolMonth is the perfect time to take advantage of this special offer and book your consultation."CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.To learn more about CoolSculpting® and CoolSculpting® Elite, the CoolMonth offerings and to find a provider near you, please visit www.CoolSculpting.com.*NO PURCHASE NECESSARY. Open to Alle Members in 50 U.S./D.C.; 18+ (19+ in AL, NE; 21+ in MS). You must register online at https://alle.com/sweeps/coolmonth between 12:00:01 AM PT on 4/1/26 and 11:59:59 PM PT on 4/30/26. See full Official Rules for all details and how to enter without purchase at https://alle.com/lp/coolmonth-official-rules.†Offers are for a limited time only and while supplies last. Terms and Conditions apply. Limited Member eligibility applies.‡Online survey conducted in 2023 of consumers aged between 25 to 55 with a household income of > $75,000 (N= 200 consumers aware of and interested in receiving body contouring within the next year)About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.comAbout AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=3994416478&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X and YouTube.Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.CoolSculpting® and CoolSculpting® Elite Uses and Important Safety InformationUsesCoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.Important Safety InformationThis procedure is not for everyone. You should not be treated with CoolSculpting® or CoolSculpting® Elite if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.Tell your doctor if you are pregnant or have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, cramping and discomfort at the treatment site. These sensations lessen as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, stinging, tenderness, cramping, skin inflammation and aching. Sensory alteration (itching, skin sensitivity, tingling, and numbness) can persist up to several weeks after treatment. You may also experience throat discomfort/soreness and sensation of fullness in the back of the throat after submental or submandibular area treatment.Rare side effects may happen in 1 to 10 out of 10,000 CoolSculpting® and CoolSculpting® Elite treatments (between 0.01% to 0.1%). One such rare side effect is a visible enlargement in the treated area, which may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.Please see full Important Safety Information for CoolSculpting® and CoolSculpting® Elite on CoolSculpting.com.REFERENCES:Data on file, Allergan, 2025; Portfolio Aesthetic Monthly Tracker; August 2025 Data Month.Data on file, Allergan, March 2023; Sizing Allergan® Attitude & Agreement on Body Contouring Journey (NIBC) Study.Stevens WG, Eagan MM, Felber C, Sarhaddi D, Orlando MV. Cryolipolysis. In: Few JW Jr, ed. The Art of Combining Surgical and Nonsurgical Techniques in Aesthetic Medicine. Thieme; 2018:132-149.Avram MM, Harry RS. Cryolipolysis™ for subcutaneous fat layer reduction. Lasers in Surgery and Medicine 2009 Dec;41(10):703-8.Zeltiq Aesthetics. User Manual CoolSculpting® Elite System CS-UM- CM3-02-EN-K. 2024.Investors:
Liz Shea
Liz.Shea @arkieboyMedia:
Ember Garrett
Ember.Garrett @was Zeus
View original content to download multimedia:https://www.prnewswire.com/news-releases/allergan-aesthetics-announces-fourth-annual-all-access-coolmonth-with-deals-on-coolsculpting-302729041.htmlSOURCE AbbVie
Original: Allergan Aesthetics Announces Fourth Annual, All-Access CoolMonth with Deals on CoolSculpting®
US Market News
3月前
Allergan Aesthetics Reinforces Scientific Differentiation and Leadership with 21 Evidence-Based E-Posters at the 2026 Aesthetic & Anti-Aging Medicine World Congress (AMWC)March 26, 2026 4:00 AM
PR Newswire (US)
- Five scientific e-posters highlight investigational neurotoxin trenibotulinumtoxinE (TrenibotE), demonstrating rapid improvement in glabellar lines (as early as 8 hours), robust and consistent efficacy, and a favorable safety profile across global patient populations- Real-world and clinical data reinforce onabotulinumtoxinA (BOTOX® Cosmetic) as a foundation for high patient satisfaction, natural-looking results, and the gateway to multimodal facial aesthetic treatment plans- Portfolio-wide results demonstrate continued investment in innovative, integrated approaches for patients and practitioners NORTH CHICAGO, Ill., March 26, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company, will present 21 scientific e-posters at the Aesthetic & Anti-Aging Medicine World Congress (AMWC) in Monaco on March 26-28, 2026, underscoring the company's industry leadership in advancing patient-centric, evidence-based innovation across the spectrum of aesthetics medicine. The data span clinical, real-world and preclinical research, reflecting a deep commitment to driving exceptional results, safety and satisfaction for practitioners and patients worldwide."At Allergan Aesthetics, our progress is driven by a dedication to generating high-quality scientific data that informs every advance we bring to aesthetic medicine," said Darin Messina, Ph.D., senior vice president, research & development, Allergan Aesthetics. "The breadth and depth of findings presented at AMWC Monaco demonstrate our commitment to equipping practitioners with meaningful scientific insights and innovative solutions, all aimed at delivering safe, effective and individualized outcomes for patients."Investigational Neurotoxin TrenibotulinumtoxinE Demonstrates Rapid Results as Early as 8 Hours and Short Duration with Consistent Efficacy and Safety
Research shows that investigational neurotoxin trenibotulinumtoxinE (TrenibotE) delivers rapid results as early as 8 hours, a short duration of 2-3 weeks, and consistent efficacy with safety observed across diverse patient populations.Key Findings:Rapid and consistent improvement in moderate-to-severe glabellar lines, with results observed as early as 8 hours and comparable efficacy and safety across East Asian and North American/European populationsEffective and well-tolerated in both toxin-naïve patients and those previously treated with onabotulinumtoxinA (BOTOX® Cosmetic), supporting use across treatment historiesHigh patient satisfaction with natural-looking results, along with improvements in psychosocial outcomes following treatmentEarly evidence supports sequential treatment with TrenibotE followed by onabotulinumtoxinA (BOTOX® Cosmetic) as a well-tolerated and effective approach for glabellar linesPoster TitleAuthorsTrenibotulinumtoxinE in Moderate-to-Severe Glabellar
Lines: Multiregional Phase 3 Safety and Efficacy in East
Asian Populations Hongyi Zhao, Jiaming Sun, Wenyu Wu, Qian Tan,
Shu-Hung Huang, Tim-Mo Chen, Mana Hirayama,
Ziyang Liu, Chung-Yi C. Chiang, Yoko Suzuki,
Bryan Ho, Amy S. Weitzenfeld, Joan-En Chang-LinTrenibotulinumtoxinE Rapidly Improves Moderate to
Severe Glabellar Lines: Pooled Phase 3 Efficacy and
Safety Across East Asian and North American/European
Trials Steve Dayan, Mana Hirayama, Shu-Hung Huang,
Edward Lain, Marion Moers-Carpi, Jiaming Sun,
Hong Yi Zhao, Chung-Yi C. Chiang, Ziyang Liu,
Grace S. Park, Amy S. Weitzenfeld, Yoko Yajima,
Joan-En Chang-LinTrenibotulinumtoxinE Efficacy and Safety for Glabellar
Lines Regardless of Prior Botulinum Toxin Use: Pooled
Phase 3 Analysis Terrance Keaney, Marion Moers-Carpi, Edward Lain,
Cheryl Burgess, Jason Rivers, Carmen Kavali,
Steve Yoelin, Chung-Yi C. Chiang, Amy S. Weitzenfeld,
Grace S. Park, Joan-En Chang-LinHigh Treatment Satisfaction, Natural Looking Results, and
Improved Appearance-Related Psychosocial Impact
from TrenibotulinumtoxinE Treatment for Glabellar Lines:
Pooled Patient Reported Outcomes from 2 Pivotal Phase 3
Trials Terrence Keaney, Daniela Greiner-Krueger,
Keith Marcus, Steve Yoelin, Marion Moers-Carpi,
Cheryl Burgess, Grace S. Park, Chung-Yi C. Chiang,
Joan-En Chang-Lin, Sandhya ShimogaSequential Administration of TrenibotulinumtoxinE and
OnabotulinumtoxinA for Glabellar Lines: A Phase 1
Evaluation C. William Hanke, Joely Kaufman-Janette,
Steve H. Dayan, Grace West, Amy S. Weitzenfeld,
Jie Shen, Stephanie Manson Brown, Mitchell F. Brin,
Mitalee TamhaneBOTOX® Cosmetic: Patient Satisfaction, Natural-Looking Results and Integrated Aesthetic Care
Recent studies on onabotulinumtoxinA (BOTOX® Cosmetic) solidify its position as the leading neuromodulator in facial aesthetics globally, delivering high patient satisfaction, natural-looking results and improved psychological well-being. New real-world data show long-term use is frequently followed by adoption of additional aesthetic treatments.Key Findings:High patient satisfaction and natural-looking results for upper facial lines, with improvements in psychological well-being among toxin-naïve patientsLong-term use of onabotulinumtoxinA (BOTOX® Cosmetic) may serve as an entry point to broader aesthetic treatment approaches for patientsPatient preference research in China identifies key factors influencing treatment decisions for masseter reduction, including procedure standardization, degree of slimming, duration, side effects and costReal-world evidence suggests patients receiving long-term onabotulinumtoxinA (BOTOX® Cosmetic) treatment often progress to multimodal care, including additional facial aesthetic procedures over timePoster TitleAuthorsGlobal Trends in Multimodal Facial Aesthetic Treatment
following OnabotulinumtoxinA for Upper Facial Lines:
Findings from a Retrospective Chart Review and
Cross-Sectional Study Ada Trindade De Almeida, Stefania Roberts,
Mansi Mukherjee, Sylvia Ramirez, Daniel P. Friedmann,
Wolfgang G. Philipp-Dormston, Shannon Humphrey,
Joy Diwa Maglambayan, Tanya Brandstetter,
Teresa Zhou, John Maltman, Maria MusumeciHigh Patient Satisfaction with Natural-Looking Results
After OnabotulinumtoxinA Treatment for Upper Facial Lines
in a Toxin-Naïve Population: A Phase 4, Open-Label,
Multicenter Study Amir Moradi, Vince Bertucci, Michael Gold,
Charles Cheng, Corey Hartman, Terrence Keaney,
Carmen Kavali, Corey Maas, Alain Michon,
Melissa Chiang, Tanya Brandstetter, John Maltman,
Edward Jierjian, Maria MusumeciMethodological Approach to Measuring Preferences and
Willingness to Pay for Botulinum Toxin Type A in Masseter
Muscle Prominence in China Using Discrete Choice
Experiment Kate Huang, Effi Yang, Rene Ai, Catherine Foley,
Shimeng Liu, Jia ChangSoft Tissue Fillers as Concomitant Treatments
to OnabotulinumtoxinA: Exploratory Findings From a
Multi-Country Retrospective Study Koenraad De Boulle, Ligia Colucci, Mansi Mukherjee,
Sylvia Ramirez, Stefania Roberts, Joy Diwa Maglambayan,
Teresa Zhou, Maria Musumeci, Carola de la GuardiaInjectable Hyaluronic Acid Treatments (VYC-12L and VYC-20L): Clinical Evidence Across Neck, Perioral and Skin Quality Indications
Data demonstrate that VYC-12L (SKINVIVE by JUVÉDERM®), a hyaluronic acid intradermal microdroplet injection, and VYC-20L (JUVÉDERM® VOLUMA® XC) are effective and well-tolerated across multiple indications, with up to 6 months of sustained improvement in neck lines, perioral lines and skin quality, alongside evidence of stability, biocompatibility and injector usability.Key Findings:VYC-12L reduces neck and perioral lines, with results sustained for up to 6 months and safety observed across study populationsVYC-12L improves skin quality, including cheek smoothness, supporting use across facial indicationsIn Chinese adults, VYC-12L demonstrates significant improvement in perioral lines with high responder rates and durability up to 6 monthsVYC-20L preclinical and usability data support stability, biocompatibility and improved injector experienceNew elongated plunger cap syringe shows improvements in injector comfort, ease of use and reduced hand fatigue compared to standard designsPoster TitleAuthorsA Multicenter, Evaluator-Blinded, Randomized, Controlled
Study of the Effectiveness and Safety of VYC-12L for
Treating Neck Lines and Improving Neck Appearance Joely Kaufman-Janette, Craig Teller, Kenneth Beer,
Jeanine Downie, Sabrina Fabi, Mahesh Devarasetty,
Smita ChawlaClinical Evaluation of VYC-12L for the Correction of
Perioral Lines: Findings from a Multicenter, Randomized
Study in Chinese Adults Yan Wu, Wei Lai, Qian Tan, Hongyi Zhao, Lei Wang,
Zuoliang Qi, Xia Kong, Smita ChawlaAssessing the Potential for Injectable HA Gel
Displacement: A 3D Imaging Study in a Rat Model Alex Pierce, Jennifer Ly, Lauren Nakab, Artem KutikovEvaluation of Degradation Kinetics and Biocompatibility of
VYC-20L HA Dermal Filler in a Rodent Model Using MRI
and Histological Analysis Artem Kutikov, Lauren NakabHyaluronic Acid Filler Aesthetic Syringe With Improved
Ergonomic Performance to Enhance End-User Experience Kevin Costello, Nathalie Dally, Caroline Mallet,
Bastien MandarouCross-linked Hyaluronic Acid Gel's Secondary Effects on
Dermal ECM Structure and Stability: A Spatial ProteomicsStudy Artem Kutikov, Alex Pierce, Natali Malkah, Lauren NakabHA-CaHA Injectables (HArmonyCa) Demonstrate Durable Skin Quality Improvements, Including in Patients Undergoing Medical Weight Loss
Clinical studies demonstrate that HA-CaHA injectables are effective and well-tolerated, delivering measurable improvements in skin quality and midface volume with results lasting up to 18 months. Subgroup analyses also suggest potential benefits in patients undergoing medical weight loss, including those treated with GLP-1 therapies.Key Findings:HA-CaHA injectables were shown to improve skin quality, including elasticity, firmness, tightening and cheek smoothness, extending beyond volumization aloneResults are durable, with improvements in midface volume and skin quality sustained for up to 18 monthsSubgroup analyses suggest HA-CaHA may improve midface volume and patient satisfaction in individuals undergoing medical weight loss, with effect observed up to 18 monthsPoster TitleAuthorsSkin Quality Enhancement and Biostimulatory Effects of
Hyaluronic Acid–Calcium Hydroxyapatite (HA-CaHA) Juliana Chieppe, Jason K. Rivers, Fernando Urdiales
Gálvez, Alicia Brestovisky, Angie Zhang, Malka Salomon,
SchumacherComplete Analysis of a 24-Month Multicenter, Evaluator-
Blinded, Randomized, Parallel-Group Study to Evaluate the
Safety and Effectiveness of a Hybrid Hyaluronic Acid and
Calcium Hydroxyapatite Injectable for Midface Soft Tissue
Augmentation Shannon Humphrey, Nestor Demosthenous, Andreas Nikolis,
Fernando Urdiales Gálvez, Malka Salomon, Andrew SchumacherTreatment of Midface Volume Deficits with a Hybrid
Hyaluronic Acid and Calcium Hydroxyapatite Injectable in
Participants Undergoing GLP-1 Medical Weight Loss: A
Safety and Efficacy Subgroup Analysis from a Pivotal StudyShannon Humphrey, Andreas Nikolis, Fernando Urdiales
Gálvez, Nestor Demosthenous, Sadiye Kus, Graeme Kerson,
Malka Salomon, Andrew SchumacherTreatment of GLP-1–Related Facial Volume Loss Using a
Sequential HA-CaHA And Vycross Filler Protocol Achieves
Facial Volume Restoration And High Treatment Satisfaction:
Results From A Retrospective, Single-Center StudyIlaria Proietti, Ahmed Yasin, Ambra RiccardiBody Contouring (CoolSculpting®) Demonstrates Continued Clinical Utility, Including in Medical Weight Loss Patients
Body contouring aesthetic procedures, such as CoolSculpting®, continue to have clinical utility in the treatment of patients with stubborn fat and may also play a role in those patients undergoing medical weight loss.Key Findings:Highly desired among women, with the abdomen and flanks reported as the most bothersome areas for stubborn fatHigh patient satisfaction with helping patients achieve fat reduction in areas resistant to diet and exerciseInduces beiging and metabolic activation in white adipose tissue, offering molecular evidence for lasting fat reduction efficacyPoster TitleAuthorsCryolipolysis through Controlled Cooling Induces
Early Beiging in White Adipose Tissue: Molecular Effects
and Clinical Perspective Natasha Mesinkovska, Agnesa Avanesian, Joel Jimenez LozanoDesire to Treat Bothersome Areas of Stubborn Body Fat
Using Noninvasive Methods: Patient Survey Findings
Among Diverse Females with Clinical Insights from
Supporting Cryolipolysis Case ReportTerrence Keaney, Brenda LaTowsky, Agnesa AvanesianCollectively, these findings highlight the effectiveness and safety of integrated, layered treatment approaches across the Allergan Aesthetics portfolio. Attendees at AMWC can expect comprehensive scientific evidence underscoring Allergan Aesthetics' leadership in neurotoxin and multimodal aesthetic treatment strategies designed to help practitioners meet evolving patient goals. E-Posters are accessible via the AMWC App and in the E-Poster area (Level -2) of the Grimaldi Forum, March 26-28, from 8:30 a.m. – 6:00 p.m.BOTOX® Cosmetic (onabotulinumtoxinA) Important InformationIndications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
- Moderate to severe platysma bands associated with platysma muscle activityIMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.WARNINGS AND PRECAUTIONSLack of Equivalency Between Botulinum Toxin ProductsThe potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).Preexisting Conditions at the Injection Site
Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications.DRUG INTERACTIONS
Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.SKINVIVE by JUVÉDERM® Injectable Gel Important InformationINDICATIONS
SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in this product.WARNINGS: Do not inject into blood vessels as this may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention should an intravascular injection occur. Treatment at specific sites should be deferred where there is an active inflammatory process or infection.PRECAUTIONS: Only healthcare professionals who have appropriate training, experience, and are knowledgeable of the anatomy at and around the injection site should use this product. As with all transcutaneous procedures, injections carry a risk of infection. The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been established. Use with caution in patients on immunosuppressive therapy. Patients taking medications that can prolong bleeding may experience increased bruising or bleeding at treatment sites. Patients may experience late onset AEs with use of injectable gel implants, including SKINVIVE by JUVÉDERM®ADVERSE EVENTS: The most commonly reported injection site responses included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most were mild, lasting 7 days or less.Please see Directions for Use or visit SKINVIVE.com for more information.SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.The investigational products described above, trenibotulinumtoxinE for the treatment of glabellar lines and SKINVIVE by JUVÉDERM® for the improvement of neck appearance, have not yet been shown to be safe and effective for their intended uses.JUVÉDERM® Collection of Fillers Important InformationINDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve moderate to severe temple hollowing in adults over the age of 21.JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occurProduct use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlledPRECAUTIONSTo minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complicationsThe potential risks of soft tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complicationsThe safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studiesThe safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studiedThe safety for use during pregnancy and in breastfeeding females has not been establishedThe safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation, 22 and 80 years of age for chin augmentation, and 32 and 82 years of age for improvement of temple hollowingThe safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC, and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been establishedDermal filler implantation carries a risk of infection. Follow standard precautionsDermal fillers should be used with caution in patients on immunosuppressive therapyPatients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sitesPatients who experience skin injury near the site of implantation may be at a higher risk for adverse eventsIf laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection siteThe safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been establishedThe safety of using a cannula with JUVÉDERM® VOLUMA® XC for cheek augmentation in patients with Fitzpatrick Skin Types V and VI or to improve temple hollowing has not been establishedJUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation studyThe effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studiedPatients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM® VOLUMA® XCBased on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been establishedInjection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studiedADVERSE EVENTS
The most common reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity.To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information.Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.About Allergan AestheticsAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.comAbout AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=861821477&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.Global Media:Michael Salzillomichael.salvillo1@allergan.com U.S. Media:Adelle Infanteadelle.infante@allergan.com Investors: Liz Shealiz.shea@abbvie.com
View original content:https://www.prnewswire.com/news-releases/allergan-aesthetics-reinforces-scientific-differentiation-and-leadership-with-21-evidence-based-e-posters-at-the-2026-aesthetic--anti-aging-medicine-world-congress-amwc-302725131.htmlSOURCE AbbVie
Original: Allergan Aesthetics Reinforces Scientific Differentiation and Leadership with 21 Evidence-Based E-Posters at the 2026 Aesthetic & Anti-Aging Medicine World Congress (AMWC)
US Market News
3月前
Allergan Aesthetics Ushers in a New Age of Hyaluronic Acid (HA) Injectables with JUVÉDERM® at AMWC MonacoMarch 26, 2026 3:00 AM
PR Newswire (US)
Research reveals an industry mindset shift towards 'undetectable†' aesthetics, as people seek a natural-looking, personalized approach and a subtle, rejuvenated appearance that is almost imperceptible1,2,‡Leading healthcare professionals discussed the findings at an Allergan Aesthetics* event at AMWC, which reaffirm 'undetectable' aesthetics, and the positive role of HA injectables in helping to achieve a discreet 'look'1,2,§The latest findings are part of Allergan Aesthetics' ongoing commitment to quality education and helping shape the future of HA injectablesTogether with trusted healthcare practitioners, the JUVÉDERM® Collection of Fillers is committed to advancing a new era of HA injectables.NORTH CHICAGO, Ill., March 26, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company, a global leader in medical aesthetics treatments and manufacturers of the market-leading JUVÉDERM® Collection of Fillers,3,4,? is once again forging ahead and has announced that the 'Undetectable† Era' will drive the next chapter in the Hyaluronic Acid (HA) injectable category at the Aesthetic & Anti-Aging Medicine World Congress (AMWC) 2026 in Monaco.For over 20 years, HA injectables have been a trusted, versatile, and clinically proven foundation of modern aesthetics.5-28, ,?,††,‡‡ §§ Today, the category and the aesthetics landscape are changing.1 Research findings discussed at an Allergan Aesthetics event at the congress identify the shift towards an 'undetectable era' of aesthetics and the role HA injectables play in helping to achieve natural-looking outcomes.1 The notion of 'undetectable' aesthetics appeals to a dominant new wave of patients who are choosing to take a longevity-based approach to ageing1. Through its market-leading portfolio of HA injectables3,4,?, JUVÉDERM® is helping to meet these consumer expectations head on. Showcasing safety, high quality design, consistent outcomes, and versatility, JUVÉDERM® offers a comprehensive solution for the modern beauty consumer.17-27,29-32Understanding the 'Undetectable' Aesthetics Era
This 'undetectable' era refers to a shift in aesthetic procedures towards patients seeking results that are subtle, natural-looking, leave no obvious traces of treatment, and are only noticeable to themselves and close acquaintances.1,33 The research reveals that today's patients don't want to look treated, they want a natural look.1,2,33,‡ This shift has already been seen in celebrity circles and amongst influencers appearing to adopt the approach with almost imperceptible aesthetic enhancements.33,34This 'undetectable' look relies on a carefully considered approach; product, quantity, and placement is key, and practitioners must employ a holistic strategy that centers around a full-face consultation. With the right product in expert hands, JUVÉDERM®'s portfolio of versatile, patented HA injectables can help achieve a refreshed, lifted, natural look, with almost imperceptible results that define the 'undetectable' aesthetics era.7-13,17,35-38, ,#,**"Natural-looking for me means preserving the patient's beauty. And that's exactly why I love the word 'undetectable.' I fully welcome the new 'undetectable era', because to achieve an undetectable look, it's important to respect the aging process and provide a natural-looking result," says Dr Juliana Chieppe, a worldclass dermatologist from Brazil who was interviewed for the research and discussed the findings on the panel at the congress.Global Patient Demand for 'Undetectable' AestheticsLayered Beauty: The New Aesthetic Mindset, is a new report launched by Allergan Aesthetics at AMWC 2026, which aims to help healthcare professionals better understand consumer needs and behaviors. The report further uncovered the shift towards 'undetectable' aesthetics. Key findings from global research39 across more than 12,000 beauty-involved consumers in nine countries found that:74% like their aesthetic results to look undetectable3971% worry about looking fake or overdone3985% like results that look natural and subtle3984% prefer products and/or treatments that give a natural-looking appearance3981% value personalized plans designed for their face and aesthetic needs39The Role of the Practitioner and HA Injectables in the 'Undetectable' Aesthetics EraAs healthcare practitioners will attest, a truly individual outcome, definitive of the 'undetectable' era, begins with the consultation.1,35,40,41 With Allergan Aesthetics' versatile JUVÉDERM® Collection of Fillers, practitioners can combine their expert knowledge and innate artistry to deliver each patient's interpretation of natural-looking beauty.7-14,42-45, ,**,# These healthcare providers leverage injection techniques that are strategically placed to lift, balance, restore volume, and enhance, and play an integral role in the 'undetectable' aesthetics era.7-14,17,35-38,40,46 HA injectables can create personalized effects that are long-lastingO, naturally fade with time, and can provide a refreshed look.7-14,24-26,31,32,35,40,47,48"HA Injectables can be tailored for the patient's needs, in addition to being supported with science-based data and a well-established safety profile and being reversible. Some injectables are 'one size fits all', and don't offer the precise tailoring of the amount that is possible with HA injectables," says Dr Juliana Chieppe.1,7-13,15-20,23-28,30,31Mark Wilson, Senior Vice President at International Allergan Aesthetics said, "In a world where 'natural' is almost impossible to define, we herald this new 'undetectable' era, which provides the language for patients to communicate, and practitioners to understand, that patients still want to look like themselves, just more glowing, healthy, and rested. Patients are seeking personalized and almost imperceptible enhancements that complement their natural features. JUVÉDERM®'s market-leading collection of HA injectables offers our practitioners the versatility to help patients achieve results that are aligned with the best version of themselves, as sought after in this 'undetectable' aesthetics era." 7-14,35,36How Allergan Aesthetics Helps Practitioners Meet Modern Patient GoalsWhile the notion of 'undetectable' aesthetics demands the highest quality product, it cannot be achieved authentically without referencing and respecting a patient's individuality. Allergan Aesthetics champions the individual approach and versatility of HA injectables and is paving the way for multimodal treatments with its innovative AA SignatureTM treatment approach.7-14,35,41,47,48 AA SignatureTM is designed to support healthcare professionals in meeting modern patient goals by using Allergan Aesthetics' advanced, versatile portfolio of products including the JUVÉDERM® Collection of Fillers.7,8,46,49-54Whether used alone or synergistically with other modalities as part of a multi-layered facial harmonization plan, HA injectables elevate and enhance other treatments, delivering powerful, personalized results.7-14,17,35-38,40,46,,**For decades, JUVÉDERM® has led the non-invasive aesthetics market with a collection of HA injectables that help patients achieve desirable, long-lastingO results.5,6,24-26,30,31,47,48,?Whether the focus is restoring volume, improving facial contours, or balancing proportions, JUVÉDERM®'s HA injectables allow practitioners to enhance or augment specific areas of the face based on patients' aesthetic goals and unique anatomy, supporting a patient's individuality.7-14,17,35-38,40,46, ,**,# With the 'undetectable' era set to dominate the beauty landscape in 2026, the power of HA injectables has never been more clear.1 Able to refine, define, and balance natural facial characteristics with efficacy, safety, and versatility, JUVÉDERM® reaffirms its central role in the future of holistic ageing and supporting subtle, natural-looking,**,# results.7-14,17-28,30-32,35-38, ††,‡‡,§§, ,**,#Celebrating 10 Years of MD CodesTM at AMWC
To celebrate more than 10 years of MD CodesTM, Allergan Aesthetics is launching Dr. Mauricio de Maio's new book: MD CodesTM: A Decade of Excellence—a compendium of real-world experience and dedication to providing a holistic approach to facial harmony.It's an extensive collection of 34 clinical case studies with before and after imagery. It is also a detailed resource for healthcare professionals, as it demonstrates the transformative results made possible by using MD CodesTM with JUVÉDERM® and the wider injectables portfolio from Allergan Aesthetics.Allergan Aesthetics is strongly committed to the health, safety, and well-being of the practitioners and patients who put their trust in its products. As part of the company's ongoing commitment to medical education, Allergan Aesthetics offers training programs for appropriate healthcare professionals on the use of JUVÉDERM® to help ensure optimal patient satisfaction and outcomes.Healthcare professionals can download the new report Layered Beauty: The New Aesthetic Mindset at https://global.allerganaesthetics.com/global-insights/layeredbeauty.Notes to Editors About Allergan Aesthetics Future of HA Injectables research
Allergan Aesthetics is heralding the era of 'undetectable' aesthetics, informed by its international research involving HCP interviews, consumer insights, industry reports, and social listening intelligence.'Undetectable' refers to an aesthetic aspiration towards subtle, natural-looking, and discreet outcomes, rather than a definitive result.To assess the current and future landscape for HA Injectables, VML conducted the following analysis on behalf of Allergan Aesthetics1:Comprehensive review of Allergan Aesthetics' proprietary global research, encompassing qualitative, quantitative, and existing social intelligence into HA injectables focused on the category, consumers, and HCPs.To understand patient and HCP conversation around HA injectables in Brazil, Thailand, and the United Kingdom, custom social listening intelligence research was conducted using the Talkwalker platform for the period January 2024 to June 2025. A further custom social listening exercise was conducted in China for the same period using the Wisers platform in August 2025.In-depth interviews with ten HCPs in Brazil, Canada, China, Thailand, and the UK were conducted in September 2025, including Dr. Babak Esfahani, Plastic & Aesthetic Surgeon (Germany), Dr. Apul Parikh, Aesthetic Doctor (UK), and Dr. Juliana Chieppe, Dermatologist (Brazil), who will form part of the panel at AMWC.About Layered Beauty: The New Aesthetic Mindset
To better understand how today's culture is reshaping aesthetic decision-making, Allergan Aesthetics commissioned a large-scale global research study spanning nine countries (Canada, United States, United Kingdom, China, Brazil, France, Germany, Thailand, and KSA) and more than 12,286 beauty-involved consumers. The study explored evolving attitudes, treatment behaviors, and expectations around combination and multimodal approaches to aesthetics, revealing a clear shift away from isolated, single interventions towards the need for integrated, personalized treatment plans delivered over time. This research was undertaken to help Allergan Aesthetics better understand these changing behaviors and support the development of structured approaches to treatment such as AA Signature™, reflecting how patients now approach aesthetics. The research was carried out in November and December 2025.About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @&h=823750731&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&a=LinkedIn%2C" target="_blank" rel="nofollow">LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit. www.allerganaesthetics.com.JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve moderate to severe temple hollowing in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occurProduct use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlledPRECAUTIONSTo minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complicationsThe potential risks of soft tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complicationsThe safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studiesThe safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studiedThe safety for use during pregnancy and in breastfeeding females has not been establishedThe safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation, 22 and 80 years of age for chin augmentation, and 32 and 82 years of age for improvement of temple hollowingThe safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC, and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been establishedDermal filler implantation carries a risk of infection. Follow standard precautionsDermal fillers should be used with caution in patients on immunosuppressive therapyPatients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sitesPatients who experience skin injury near the site of implantation may be at a higher risk for adverse eventsIf laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection siteThe safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been establishedThe safety of using a cannula with JUVÉDERM® VOLUMA® XC for cheek augmentation in patients with Fitzpatrick Skin Types V and VI or to improve temple hollowing has not been establishedJUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation studyThe effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studiedPatients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM® VOLUMA® XCBased on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been establishedInjection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studiedADVERSE EVENTS
The most common reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.DFU Links– added to end of ISI on HCP website
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus-xc_dfu.pdf for JUVÉDERM® Ultra Plus XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® Ultra XCForward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.Global Media:Michael Salzillomichael.salzillo@abbvie.com U.S. Media:Adelle Infante Adelle.infante@abbvie.com Investors: Liz SheaLiz.shea@abbvie.com Disclaimers
Material developed and funded by Allergan Aesthetics, an AbbVie company.
Copyright 2026 AbbVie. All rights reserved. All trademarks are the property of their respective owners.Footnotes
†'Undetectable' refers to an aesthetic aspiration towards subtle, natural-looking, and discreet outcomes, rather than a definitive result.‡Based on a 30-minute online quantitative survey among aesthetics consumers across seven global markets. Respondents answered Q33: "When you think about 'fillers', how much do you agree or disagree with the following statements? Base: n=5306. Data labels
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