US Market News
4月前
Medincell : La FDA américaine accepte le dossier de demande de mise sur le marché déposé par Teva pour l’Olanzapine LAIFebruary 20, 2026 3:37 PM
Business Wire
Olanzapine LAI (TEV-’749 / mdc-TJK) est une suspension injectable d’olanzapine à libération prolongée pour le traitement de la schizophrénie chez l’adulte, administrée une fois par mois
L’Olanzapine LAI pourrait offrir l’efficacité de l’olanzapine en injection sous-cutanée administrée mensuellement1.
Si elle est approuvée après l’examen du dossier par la FDA2, l’Olanzapine LAI pourrait contribuer à répondre à un besoin médical important encore non satisfait dans le traitement de la schizophrénie, en comblant l’absence de formulations viables d’olanzapine à action prolongée1.
Teva poursuit le développement de cette option thérapeutique innovante et le renforcement de son portefeuille différencié de traitements injectables à action prolongée (LAI), consolidant ainsi son leadership scientifique dans les pathologies neurologiques complexes, dans le cadre de sa stratégie Pivot to Growth.
Regulatory News:
Teva Pharmaceuticals, filiale américaine de Teva Pharmaceutical Industries Ltd. (NYSE et TASE : TEVA), et Medincell (Euronext : MEDCL), annoncent que la Food and Drug Administration (FDA) américaine a accepté le dossier de demande d'autorisation de mise sur le marché américain (NDA) de l’injection sous-cutanée à libération prolongée d’olanzapine (TEV-‘749) pour le traitement de la schizophrénie chez l’adulte. L’Olanzapine LAI est conçue pour favoriser l’observance dans la vie réelle et améliorer la stabilité clinique, avec un objectif de répondre à un besoin thérapeutique majeur pour les personnes atteintes de schizophrénie.
À ce jour, il n’existe aucune formulation d’olanzapine à action prolongée qui ne soit soumise à un plan de gestion des risques (Risk Evaluation and Mitigation Strategy – REMS) exigé par la FDA. Ce dispositif impose une administration dans un établissement de santé certifié ainsi qu’une période de surveillance de trois heures après l’injection. Dans l’étude de phase 3 SOLARIS, l’olanzapine LAI, administrée une fois par mois par injection sous-cutanée, a démontré un profil d’efficacité et de tolérance comparable à celui des formulations d’olanzapine actuellement disponibles, sans mettre en évidence la nécessité d’une surveillance post-injection.
« L’observance thérapeutique reste un défi majeur et un besoin médical non satisfait pour les personnes vivant avec une schizophrénie, en particulier celles traitées par olanzapine orale. Notre olanzapine injectable à libération prolongée, administrée par voie sous-cutanée, pourrait apporter une plus grande stabilité en offrant l’efficacité et la sécurité éprouvées de l’olanzapine sous la forme d’un traitement mensuel », a déclaré Eric Hughes, MD, PhD, vice-président exécutif R&D mondiale et directeur médical de Teva. « L’absence d’une formulation d’olanzapine à action prolongée viable a, pendant trop longtemps, limité les options thérapeutiques disponibles. Nous sommes impatients de travailler avec la FDA dans le cadre de l’examen de cette demande afin de contribuer à répondre à ce besoin médical non satisfait. »
« L'olanzapine sous forme quotidienne est l'un des antipsychotiques les plus couramment prescrits aux personnes atteintes de schizophrénie, et une formulation à libération prolongée pourrait mieux s'adapter à leur quotidien », a déclaré Christophe Douat, Directeur Général de Medincell. « À mesure que le recours aux traitements injectables à libération prolongée progresse, ils sont de plus en plus reconnus comme une option thérapeutique essentielle pour la prise en charge des troubles psychiatriques sévères. Le potentiel d’un traitement à libération prolongée pratique et adapté est donc considérable. »
La demande de mise sur le marché (NDA) pour l’Olanzapine LAI repose sur les résultats de l'essai SOLARIS de phase III, y compris les résultats à 56 semaines évaluant son efficacité, son innocuité et sa tolérance chez des participants âgés de 18 à 64 ans atteints de schizophrénie1. Les résultats ont démontré un profil d'efficacité et d'innocuité conforme à celui des formulations d'olanzapine actuellement disponibles1.
L’Olanzapine LAI est une injection sous-cutanée, expérimentale, mensuelle, à libération prolongée unique de deuxième génération, d'olanzapine, un antipsychotique atypique. Elle n'est actuellement approuvée par aucune autorité réglementaire pour quelque usage que ce soit.
L’Olanzapine LAI utilise SteadyTeq™, une technologie de copolymère propriétaire de Medincell qui assure une libération contrôlée, régulière et prolongée de l'olanzapine.
À propos de l’étude sur l’injection sous-cutanée d’olanzapine à libération prolongée (SOLARIS)
SOLARIS est une étude internationale, multicentrique, randomisée, en double aveugle, avec groupes parallèles et contrôle placebo, visant à évaluer l’efficacité, la sécurité et la tolérance de l’injection sous-cutanée à libération prolongée d’olanzapine chez des patients âgés de 18 à 64 ans atteints de schizophrénie1.
Pour la première période de l’étude (les 8 premières semaines), 675 patients ont été randomisés pour recevoir une injection sous-cutanée mensuelle d’olanzapine LAI (TEV-749) à faible, moyenne ou forte dose, ou un placebo, selon un ratio 1:1:1:11. Pour la deuxième période (les 48 semaines suivantes), les patients ayant terminé la première période ont été randomisés et répartis de manière équitable dans l’un des trois groupes de traitement par olanzapine LAI (TEV-749)1. Les visites de fin de traitement et de suivi ont eu lieu respectivement 4 et 8 semaines après l’administration de la dernière dose1.
L’objectif principal de l’étude de Phase 3 SOLARIS était d’évaluer l’efficacité de l’olanzapine LAI (TEV-749) chez des patients adultes atteints de schizophrénie1. Un objectif secondaire clé consistait à évaluer plus en détail son efficacité à partir de paramètres supplémentaires1. Un objectif secondaire de la deuxième période de l’étude était d’évaluer la sécurité et la tolérance de l’olanzapine LAI (TEV-749) chez les patients adultes1.
À propos de la schizophrénie
La schizophrénie est un trouble mental chronique, évolutif et gravement invalidant qui affecte la pensée, les émotions et le comportement2. Les patients présentent une variété de symptômes, pouvant inclure des délires, des hallucinations, un langage ou un comportement désorganisé, ainsi qu’une altération des capacités cognitives.,3,4,5
Environ 1 % de la population mondiale développera une schizophrénie au cours de sa vie, et 3,5 millions de personnes aux États-Unis sont actuellement diagnostiquées4,5. Bien que la schizophrénie puisse survenir à tout âge, l’âge moyen d’apparition se situe généralement à la fin de l’adolescence ou au début de la vingtaine pour les hommes, et à la fin de la vingtaine ou au début de la trentaine pour les femmes5.
L’évolution à long terme de la schizophrénie est marquée par des épisodes de rémission partielle ou complète entrecoupés de rechutes, souvent dans le cadre d’urgences psychiatriques nécessitant une hospitalisation4. Environ 80 % des patients connaissent plusieurs rechutes au cours des cinq premières années de traitement, chaque rechute entraînant un risque biologique de perte de fonction, de résistance au traitement et de modifications de la morphologie cérébrale.6,7,8
Les patients ne sont souvent pas conscients de leur maladie et de ses conséquences, ce qui contribue à la non-observance du traitement, à un taux élevé d’abandon et, in fine, à des coûts de santé directs et indirects significatifs liés aux rechutes et aux hospitalisations ultérieures.3,4,5,6,7,8
A propos de Medincell
Medincell est une société de licensing biopharmaceutique en phase clinique et commerciale qui développe des traitements injectables à action prolongée dans de nombreux domaines thérapeutiques. Nos traitements innovants visent à garantir le respect des prescriptions médicales, à améliorer l'efficacité et l'accessibilité des médicaments et à réduire leur empreinte environnementale.
Ils combinent des principes actifs avec nos technologies propriétaires BEPO®, qui contrôlent la libération d'un médicament à un niveau thérapeutique pendant plusieurs jours, semaines ou mois à partir de l'injection sous-cutanée ou locale d'un simple dépôt entièrement biorésorbable.
La rispéridone LAI est le premier traitement utilisant la technologie BEPO® à avoir été approuvé par la FDA, d'abord pour la schizophrénie en avril 2023, puis pour le trouble bipolaire I en octobre 2025. Il est commercialisé aux États-Unis par Teva sous le nom d'UZEDY® (la technologie BEPO est licenciée à Teva sous le nom de SteadyTeq™). La rispéridone LAI de Medincell a également été approuvée pour la schizophrénie au Canada et en Corée du Sud en 2025.
Une demande d’autorisation de mise sur le marché pour l’Olanzapine LAI en traitement mensuel de la schizophrénie chez l’adulte a été soumise à la FDA américaine en décembre 2025 par le partenaire de Medincell, Teva.
Notre pipeline comprend de nombreux candidats médicaments innovants à différents stades de développement, de la formulation aux essais cliniques de phase 3. Nous collaborons avec des entreprises pharmaceutiques de premier plan et des fondations pour améliorer la santé dans le monde grâce à de nouvelles options de traitement.
Basée à Montpellier, Medincell emploie plus de 140 personnes représentant plus de 25 nationalités différentes.
medincell.com
UZEDY® et SteadyTeq™ sont des marques déposées de Teva Pharmaceuticals
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Une liste et une description de ces risques, éventualités et incertitudes figurent dans les documents déposés par la Société auprès de l'Autorité des marchés financiers (l'« AMF ») conformément à ses obligations réglementaires, notamment le document d’enregistrement universel de la Société, déposé auprès de l'AMF le 29 juillet 2025 sous le numéro D. 25-0580 (le « Document d'enregistrement universel »), ainsi que dans les documents et rapports qui seront publiés ultérieurement par la Société. L'attention des lecteurs est notamment attirée sur la section intitulée « Facteurs de risques » à la page 30 et suivantes 26 du Document d'enregistrement.
Les déclarations prospectives faites par ou au nom de la Société ne sont valables qu'à la date à laquelle elles sont faites. Sauf si la loi l'exige, la Société ne s'engage aucunement à mettre à jour publiquement ces déclarations prospectives ou à mettre à jour les raisons pour lesquelles les résultats réels pourraient différer sensiblement de ceux anticipés dans les déclarations prospectives, y compris dans le cas où de nouvelles informations seraient disponibles. La mise à jour par la Société d'une ou plusieurs déclarations prospectives n'implique pas que la Société procédera à d'autres mises à jour de ces déclarations prospectives ou d'autres déclarations prospectives. Les lecteurs sont priés de ne pas se fier indûment à ces déclarations prospectives.
Le présent communiqué de presse est publié à titre informatif uniquement. Les informations qu'il contient ne constituent pas une offre de vente ni une sollicitation d'offre d'achat ou de souscription d'actions de la Société dans quelque juridiction que ce soit, en particulier en France. De même, le présent communiqué de presse ne constitue pas un conseil en investissement et ne doit pas être considéré comme tel. Il n'est pas lié aux objectifs d'investissement, à la situation financière ou aux besoins spécifiques d'un destinataire quelconque. Il ne doit pas priver les destinataires de la possibilité d'exercer leur propre jugement. Toutes les opinions exprimées dans le présent document sont susceptibles d'être modifiées sans préavis. La diffusion du présent communiqué de presse peut être soumise à des restrictions légales dans certaines juridictions.
1 Données internes. Parsippany, NJ: Teva Neuroscience, Inc.
2 L’acceptation d’une demande de mise sur le marché par la FDA américaine, ouvre une période d’environ 8 mois pour un examen standard du dossier.
3 Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
4 Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
5 Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
6 Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
7 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
8 Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.
Consultez la version source sur businesswire.com : https://www.businesswire.com/news/home/20260220195437/fr/
David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@MedinCell.com / +33 (0)6 83 25 21 86
Grace Kim
Chief Strategy Officer, U.S. Finance
US Market News
4月前
Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in AdultsFebruary 20, 2026 3:37 PM
Business Wire
Olanzapine long-acting injectable suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation 1
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations1
Teva is committed to advancing this innovative treatment option and further building on its differentiated LAI franchise and scientific leadership in complex neurological conditions as it drives forward its Pivot to Growth strategy
Regulatory News:
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.
Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.
“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV-'749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-'749 to help address this gap in care.”
“Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia, and this long-acting formulation may better fit into their lives,” said Christophe Douat, CEO of Medincell. “As experience with long-acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions. The potential reach of a practical long-acting option is significant.”
The NDA for TEV-'749 is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.1 The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.1
TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation atypical antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.
TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.
About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-'749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-'749) based on additional parameters in adult patients with schizophrenia.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.1
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.2 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.4 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.2,3,4,5,6,7
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This Press Release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia and to obtain regulatory FDA approval; our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.
Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.
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Original: Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults
US Market News
5月前
Teva Canada Announces Approval of Expanded Indication of [Pr]AJOVY® (fremanezumab solution for subcutaneous injection), the First Anti-CGRP Preventive Treatment for Pediatric Episodic MigraineFebruary 4, 2026 8:05 AM
PR Newswire (Canada)
Health Canada approves PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg.PrAJOVY® increases availability across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults.This approval marks an important step in enhancing the impact of PrAJOVY® beyond adults since its Canadian approval in 2020, and underscores Teva's ongoing efforts to advance and address neurological challenges.TORONTO, Feb. 4, 2026 /CNW/ - Teva Canada Limited (Teva Canada) announced today that Health Canada has approved an expanded indication for PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. With this approval, PrAJOVY® becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for eligible pediatric patients, marking a meaningful advancement in expanding preventive treatment options for those living with migraine.
Migraine is a neurological disease that significantly impacts children and adolescents leading to missed school, reduced social participation, and wide-ranging effects on family life. With this approval, PrAJOVY® now offers a new, once-monthly preventive option to help reduce the frequency of migraine attacks for eligible pediatric patients."Migraine has a profound impact on children and teens, yet pediatric patients have historically had very few preventive treatment options", said Wendy Gerhart, Executive Director of Migraine Canada. "We welcome this approval as a meaningful step forward for families navigating this challenging condition. Having additional, evidence-based choices matters and may make a measurable difference in the day-to-day lives of young people living with migraine."Health Canada's approval of this indication is based on the results of Phase 3 SPACE trial, which demonstrated that fremanezumab significantly reduced monthly migraine days and monthly headache days versus placebo over a 12–week period in pediatric patients with episodic migraine and showed a safety profile consistent with adults.1"As an investigator in the clinical study that supported this approval, I've seen firsthand the meaningful impact fremanezumab may have for young people living with episodic migraine", said Dr. Daniela Pohl, MD, PhD, Professor of Pediatric Neurology at the Children's Hospital of Eastern Ontario. "This is an important advancement for Canadian children and adolescents who have long lacked evidence-based preventive options. Having AJOVY available to this population gives clinicians and families a targeted therapy that can help reduce migraine burden and improve day-to-day well-being."We are proud to bring this important advancement to pediatric migraine care in Canada," said Fabien Paquette, General Manager of Teva Canada. "This approval reflects Teva's commitment to helping patients across all stages of life, and to ensuring families have innovative therapies backed by strong clinical science. Expanding the availability of AJOVY to younger Canadians underscores our long-standing dedication to neurological health and to closing gaps in care.About PrAJOVY®
PrAJOVY® is indicated for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. PrAJOVY® is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. PrAJOVY® can be administered either by a healthcare professional or at home by a patient 13 years of age or older or caregiver. No starting dose is required to begin treatment.About SPACE
SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12–week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.About Teva Canada
Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is proud to celebrate 60 years of serving the health of Canadians. As one of the world's largest suppliers of generic, biosimilar, and innovative medicines, we are all in for better health — committed to delivering reliable, high-quality treatments. With facilities in Markham, Stouffville, Toronto, and Montréal, we employ over 850 people and manufacture 70% of the medicines we sell in Canada locally, reinforcing our commitment to accessibility and supporting the Canadian economy. Learn more at www.tevacanada.com.Cautionary Note Regarding Forward–Looking Statements
This release includes forward–looking statements that are based on Teva's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include regulatory, market, and commercial factors, as well as those described in Teva's publicly filed reports. Forward–looking statements speak only as of the date of this release, and Teva undertakes no obligation to update them except as required by law_____________________________1 Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo–Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine. New England Journal of Medicine.
SOURCE Teva Canada
Original: Teva Canada Announces Approval of Expanded Indication of [Pr]AJOVY® (fremanezumab solution for subcutaneous injection), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine
US Market News
5月前
Teva Canada annonce l'approbation de l'indication élargie de [Pr]AJOVY[MD] (frémanézumab, solution pour injection sous cutanée), le premier traitement préventif anti-CGRP indiqué pour la migraine épisodique pédiatriqueFebruary 4, 2026 8:05 AM
PR Newswire (Canada)
Santé Canada approuve PrAJOVYMD (frémanézumab, solution pour injection sous-cutanée) pour la prévention de la migraine épisodique (moins de 15 jours de migraine par mois) chez les patients pédiatriques de 6 à 17 ans et pesant au moins 45 kg.PrAJOVYMD élargit l'accès dans tous les groupes d'âge en tant que premier et seul antagoniste du peptide lié au gène de la calcitonine (CGRP) approuvé pour la prévention de la migraine épisodique pédiatrique et la prévention de la migraine chez les adultes.Cette approbation marque une étape importante dans l'élargissement de l'impact de PrAJOVYMD au delà de la population adulte depuis son approbation au Canada en 2020 et souligne les efforts continus de Teva pour faire progresser la neurologie et relever les défis inhérents.TORONTO, le 4 févr. 2026 /CNW/ - Teva Canada Limitée (Teva Canada) a annoncé aujourd'hui que Santé Canada a approuvé une indication élargie pour PrAJOVYMD (frémanézumab, solution pour injection sous-cutanée) destinée à prévenir la migraine épisodique (moins de 15 jours de migraine par mois) chez les patients pédiatriques âgés de 6 à 17 ans et pesant au moins 45 kg. Avec cette approbation, PrAJOVYMD devient le premier et seul antagoniste du peptide lié au gène de la calcitonine (CGRP) indiqué pour les patients pédiatriques admissibles, ce qui marque un progrès significatif dans l'élargissement des choix thérapeutiques préventifs pour les personnes vivant avec la migraine.
La migraine est une maladie neurologique qui a un impact significatif sur les enfants et les adolescents, entraînant des absences scolaires, une participation sociale réduite et des effets variés sur la vie familiale. Grâce à cette approbation, PrAJOVYMD offre désormais un nouveau choix thérapeutique préventif à administration mensuelle qui pourra contribuer à réduire la fréquence des crises de migraine chez les patients pédiatriques admissibles.« La migraine a un impact profond sur les enfants et les adolescents; pourtant, les patients pédiatriques ont disposé historiquement de très peu de choix thérapeutiques préventifs, a déclaré Wendy Gerhart, directrice générale de Migraine Canada. Nous accueillons favorablement cette approbation, qui représente une avancée importante pour les familles confrontées à cette affection tenace. Des choix additionnels fondés sur des données probantes sont importants et peuvent avoir une influence appréciable sur la vie quotidienne des jeunes vivant avec la migraine. »L'approbation de cette indication par Santé Canada repose sur les résultats de l'essai de phase 3 SPACE, qui a démontré que le frémanézumab réduisait de manière significative le nombre de jours mensuels de migraine et de céphalées par rapport au placebo sur une période de 12 semaines chez les patients pédiatriques atteints de migraine épisodique, tout en présentant un profil d'innocuité cohérent avec le profil observé chez les adultes1.« En tant qu'investigatrice de l'étude clinique ayant soutenu cette approbation, j'ai pu constater directement l'impact significatif que le frémanézumab peut avoir chez les jeunes vivant avec la migraine épisodique, a déclaré la Dre Daniela Pohl, MD, Ph. D., professeure de neurologie pédiatrique au Children's Hospital of Eastern Ontario. Il s'agit d'une avancée importante pour les enfants et les adolescents au Canada, qui ont longtemps manqué de choix préventifs fondés sur des données probantes. Le fait qu'AJOVY soit maintenant accessible à cette population offre aux cliniciens et aux familles un traitement ciblé qui pourra aider à réduire le fardeau de la migraine et améliorer le bien-être au quotidien. »« Nous sommes fiers d'apporter cette avancée importante aux soins de la migraine pédiatrique au Canada, a affirmé Fabien Paquette, directeur général de Teva Canada. Cette approbation reflète l'engagement de Teva à aider les patients à toutes les étapes de la vie et à offrir aux familles des traitements innovants appuyés par une science clinique robuste. L'élargissement de l'accès à PrAJOVYMD pour les jeunes Canadiens souligne notre dévouement de longue date à la santé neurologique et la réduction des lacunes en matière de soins. »À propos de PrAJOVYMDPrAJOVYMD est indiqué pour la prévention de la migraine épisodique (moins de 15 jours de migraine par mois) chez les patients pédiatriques de 6 à 17 ans pesant au moins 45 kg. PrAJOVYMD est offert sous forme d'injection unidose de 225 mg/1,5 mL dans un auto-injecteur prérempli ou une seringue préremplie. PrAJOVYMD peut être administré par un professionnel de la santé ou à domicile par un patient de 13 ans ou plus, ou par un aidant. Aucune dose initiale n'est requise pour amorcer le traitement.À propos de l'essai SPACESPACE est une étude multicentrique randomisée à double insu contrôlée par placebo, menée selon un modèle en groupes parallèles, comparant l'efficacité, l'innocuité et la tolérabilité du frémanézumab administré par voie sous-cutanée à celles du placebo sur une période de 12 semaines pour le traitement préventif de la migraine épisodique chez 237 patients pédiatriques âgés de 6 à 17 ans.À propos de Teva CanadaTeva Canada Limitée, une filiale de Teva Pharmaceutical Industries Ltd. (NYSE et TASE : TEVA), est fière de célébrer 60 ans au service de la santé des Canadiens. En tant que l'un des plus importants fournisseurs mondiaux de médicaments génériques, biosimilaires et innovants, nous avons tous à cœur d'améliorer la santé, et nous nous engageons à offrir des traitements fiables de haute qualité. Avec des installations à Markham, Stouffville, Toronto et Montréal, nous employons plus de 850 personnes et fabriquons localement 70 % des médicaments que nous vendons au Canada, renforçant ainsi notre engagement envers l'accessibilité et l'économie canadienne. Pour en savoir plus : www.tevacanada.com.Note concernant les énoncés prospectifsLe présent communiqué contient des énoncés prospectifs qui sont basés sur les attentes actuelles de Teva et qui peuvent comporter des risques et incertitudes pouvant entraîner des résultats réels qui diffèrent sensiblement des énoncés. Ces risques incluent des facteurs réglementaires, des facteurs commerciaux et des facteurs liés au marché, de même que les facteurs décrits dans les documents publics déposés par Teva. Les énoncés prospectifs ne valent qu'en date du présent communiqué, et Teva n'assume aucune obligation de les mettre à jour, sauf si la loi l'exige.
_____________________________________
1 Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo-Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine. New England Journal of Medicine.
SOURCE Teva Canada
Original: Teva Canada annonce l'approbation de l'indication élargie de [Pr]AJOVY[MD] (frémanézumab, solution pour injection sous cutanée), le premier traitement préventif anti-CGRP indiqué pour la migraine épisodique pédiatrique
midastouch017
8月前
Teva Kicks Off ‘The Other TD’ to Raise Awareness of Tardive Dyskinesia (TD), with Support from Pro Football Hall of Famer Terrell Davis
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the launch of ‘The Other TD,’ a disease education campaign leveraging the broad recognition of football touchdowns to raise awareness and understanding of a lesser-known TD – tardive dyskinesia. The goal of the campaign is to help undiagnosed Americans living with TD, and their care partners, recognize symptoms and take action by having conversations with their healthcare provider. Terrell Davis, known for his iconic initials, “TD,” and for scoring dozens of touchdowns in his career, is partnering with Teva to shine a light on ‘The Other TD’.
15.4 million Americans are living with a serious mental illness,8 such as bipolar disorder, major depressive disorder, or schizophrenia, with many using antipsychotic medications to treat these conditions. While these treatments can provide much needed relief to patients, 25% of those taking certain mental health treatments may develop uncontrollable movements, known as TD.2,9,10 This disorder can make everyday tasks like eating, getting dressed, and walking difficult,1-2 but it can be treated without interrupting your mental health progress.4
“As someone who has faced my own mental health challenges, I understand the importance of speaking out and providing support for those encountering similar obstacles,” said Terrell Davis, Pro Football Hall of Famer and 2x champion. “Because of this, I am honored to be partnering with Teva to use my name and platform to increase awareness around TD and empower those who might be struggling to learn more and seek treatment.”
‘The Other TD’ provides educational information about TD, including how to recognize symptoms and its physical, emotional, social, and functional impacts. Additional resources for patients about treatment options and tips for care partners are also available.
Despite its estimated impact on 785,000 Americans, only approximately 15% receive a formal TD diagnosis and only 5% receive treatment.3 Underdiagnosis is especially high among younger individuals, men, and racial and ethnic minority groups, including Black Americans who have lower rates of formal TD diagnoses despite their TD movements being recognized an average of seven years prior.5-7 The effects of TD, however, are not solely physical. In fact, three out of four people who have TD say it severely impacts how they function, feel, and interact with others.1-3
“‘The Other TD’ emphasizes our commitment to TD patients seeking treatment and support, to those who may have TD but not know it, and to care partners looking to support their loved ones,” said Heather DeMyers, Vice President, U.S. Innovative Medicines Marketing at Teva. “Ultimately, we want individuals to know if they are suffering from the impacts of TD—they are not alone. While TD may impact their daily life, there are effective treatment options available that don’t have to interfere with their mental health journey.”
Please visit TheOtherTD.com to learn more about typical TD symptoms and potential treatment options.
midastouch017
10月前
Teva Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss
August 28 2025 - 8:30AM
Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the FDA approval and U.S. launch of a generic version of Saxenda®1 (liraglutide injection).
“With this approval, and by launching a generic for Saxenda® (liraglutide injection), we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,” said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. “This is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva's diverse complex generics portfolio, demonstrating once again our proven ability to sustain a world class Generics Powerhouse.”
Saxenda® had annual sales of $165 million as of June 2025.2
What is Liraglutide Injection?
Liraglutide Injection is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:
Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
Adults with overweight in the presence of at least one weight-related comorbid condition.
Liraglutide injection should be used with a reduced calorie diet and increased physical activity.
Liraglutide injection is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists.
It is not known if liraglutide injection is safe and effective in children under 12 years of age.
It is not known if liraglutide injection is safe and effective in children aged 12 to 17 years with type 2 diabetes.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about liraglutide injection?
Serious side effects may happen in people who take liraglutide injection, including:
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide injection and medicines that work like liraglutide injection caused thyroid tumors, including thyroid cancer. It is not known if liraglutide injection will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use liraglutide injection if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Who should not take liraglutide injection?
Do not receive liraglutide injection if:
you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you have had a serious allergic reaction to liraglutide or any of the ingredients in liraglutide injection. See “What are the possible side effects of liraglutide injection?” for symptoms of a serious allergic reaction.
Before taking liraglutide injection tell your healthcare provider about all of your medical conditions, including if you:
have or have had problems with your pancreas
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
have or have had depression or suicidal thoughts, or mental health issues.
are breastfeeding or plan to breastfeed. It is not known if liraglutide passes into your breast milk. You and your healthcare provider should decide if you will use liraglutide injection or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Liraglutide injection may affect the way some medicines work and some other medicines may affect the way liraglutide injection works.
Tell your healthcare provider if you take diabetes medicines, especially insulin and sulfonylurea medicines. Talk with your healthcare provider if you are not sure if you take any of these medicines. Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of liraglutide injection?
Liraglutide Injection may cause serious side effects, including:
inflammation of the pancreas (pancreatitis). Stop using liraglutide injection and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to your back
increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes especially those who also take medicines to treat type 2 diabetes mellitus such as an insulin or a sulfonylureas and in children who are 12 years of age and older without type 2 diabetes mellitus. Low blood sugar in patients with adults with type 2 diabetes and in children without type 2 diabetes mellitus who receive liraglutide injection can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking liraglutide injection and while you take liraglutide injection.
Signs and symptoms of low blood sugar may include:
dizziness or light-headedness
sweating
confusion or drowsiness
headache
blurred vision
slurred speech
shakiness
fast heartbeat
anxiety, irritability, or mood changes
hunger
weakness
feeling jittery
Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking liraglutide injection and while you take liraglutide injection.
increased heart rate. Liraglutide injection can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate while you take liraglutide injection. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use liraglutide injection. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
serious allergic reactions. Stop using liraglutide injection, and get medical help right away if you have any symptoms of a serious allergic reaction including:
swelling of your face, lips, tongue, or throat
problems breathing or swallowing
severe rash or itching
fainting or feeling dizzy
very rapid heartbeat
gallbladder problems. Liraglutide injection may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms:
pain in your upper stomach (abdomen)
fever
yellowing of your skin or eyes (jaundice)
clay-colored stools
depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Liraglutide injection may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking liraglutide injection before you are scheduled to have surgery or other procedures.
The most common side effects of liraglutide injection in adults include:
nausea
diarrhea
constipation
vomiting
injection site reaction
low blood sugar (hypoglycemia)
headache
upset stomach (dyspepsia)
tiredness (fatigue)
dizziness
stomach pain
change in enzyme (lipase) levels in your blood
Additional common side effects in children are fever and gastroenteritis.
Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of liraglutide injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read the Medication Guide in the full Prescribing Information, including Boxed Warning.
midastouch017
1年前
Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine
https://finance.yahoo.com/news/final-data-teva-pearl-real-070000414.html
Final analysis of PEARL real world migraine prevention study presented at 11th Congress of the European Academy of Neurology (EAN 2025) Congress in Helsinki1,2
Fremanezumab demonstrated sustained effectiveness and a favourable safety and tolerability profile over the two-year study period1,2
Injection adherence remained high throughout the study (~90%), while over 75% of patients completed the study duration1
TEL AVIV, Israel, June 23, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed that AJOVY (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine.1
The final data was presented at the Congress of the European Academy of Neurology (EAN 2025) congress in Helsinki confirming that primary and secondary endpoints had been met.1 Investigators concluded that the findings underscore the sustained effectiveness and the robust injection adherence rates to long-term fremanezumab treatment in migraine prevention.1
“Over the last two years, we have observed the benefit of fremanezumab for sustained migraine prevention and its positive impact on patient outcomes,” says Messoud Ashina, Professor and Director of the Human Migraine Research Unit, the Danish Headache Center and Department of Neurology. “The PEARL study has provided valuable insight, not only
into the pivotal role that fremanezumab can play in migraine prevention, but also in the importance of real-world studies in helping build our knowledge and shape clinical practice.”
PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM). The final study showed
that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a =50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment benefitted from sustained migraine prevention for over 24 months. Injection adherence rates remained high throughout (~90%) the study, with over 75% (854/1129) of participants completing the study duration.1
The investigators also noted the favourable long-term safety and tolerability of fremanezumab that was consistent with its known safety profile from previous PEARL interim analyses and randomised controlled trials, supporting its continued clinical use for migraine prevention.2
“The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine,” said Pinar Kokturk, M.D., Vice President and Head of Medical Affairs Europe at Teva. “These data provide valuable real-world evidence supporting fremanezumab’s sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy. With migraine being the second leading cause of disability worldwide,3 the recognition of CGRP-pathway therapies by health authorities is critical for improving patient outcomes.”
Editors’ Notes
PEARL (Pan-European Real-World study), a two-year prospective, observational Phase IV study is investigating the effectiveness of AJOVY® (fremanezumab) in 1140 patients with chronic or episodic migraine. Fremanezumab is a humanised monoclonal antibody (mAb) that selectively targets the calcitonin gene-related peptide (CGRP) pathway. Of the 1140 participants enrolled, 1129 were included in the effectiveness analysis (EM, 33.1%; CM, 66.9%; 87.2% female). Eligible participants were adults with EM or CM receiving fremanezumab for migraine prevention, who maintained a daily headache diary prior to and throughout the study period. The primary endpoint was the proportion of participants with >=50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Secondary endpoints across Months 1–24 included mean change from baseline in MMD, and treatment adherence (participants who took their prescribed dose within ±5 days of the scheduled monthly/quarterly dosing regimen, per injection) and persistence.
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly
dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a health care professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
Information for Europe about AJOVY can be found here.
midastouch017
1年前
Teva Reaffirms “Pivot to Growth” Strategy Progress with Launch of Acceleration Phase at 2025 Innovation and Strategy Day
Teva outlines acceleration path into a leading biopharma company
Innovative medicines franchise on track to exceed $5 billion by 2030, led by AUSTEDO® (deutetrabenazine), AJOVY® (fremanezumab), UZEDY® (risperidone) and late-stage pipeline with blockbuster potential
Reaffirming 2027 financial targets, including 30% operating profit margin, driven by innovative growth and transformation programs
TEL AVIV, Israel and PARSIPPANY, N.J., May 29, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is hosting today a 2025 Innovation & Strategy Day, to launch the acceleration phase of its “Pivot to Growth” strategy and to discuss portfolio priorities as it evolves into a global biopharmaceutical leader. The event, led by President and CEO Richard Francis and members of Teva’s executive management team, will outline the company’s strategy, progress and roadmap to deliver sustained shareholder value through 2030 and beyond.
Presentations begin at 8:30 a.m. Eastern Time and are expected to conclude at 12:30 p.m. Eastern Time. A live webcast of the event and presentation materials will be available on Teva's Investor Relations website at: https://ir.tevapharm.com/Events-and-Presentations.
Where We Are Today
Teva has completed Phase 1 of the Strategy: Return to Growth, delivering:
9 consecutive quarters of growth – fueled by strong momentum from key innovative growth drivers.
More than $2.3 billion in revenue in 2024 from Teva’s innovative portfolio: AUSTEDO®, AJOVY®, and UZEDY®.
Returning the generics business to growth with +5% in revenues across regions, and top 3 global portfolio with potential for five product launches by 2027.
“The past two years have been about returning to growth and building a solid foundation. Today, Teva is a fundamentally different company – more focused, more innovative, and more robust. I am proud that we have delivered on our commitments,” said Richard Francis, Teva’s President and CEO. “Now, we are accelerating our growth into a leading biopharma company with a strong innovative medicines franchise and a powerhouse generics and biosimilars portfolio.”
Delivering on Our Growth Engines
Teva’s innovative portfolio continues to drive strong performance and future potential. The company has announced its target to build a >$5 billion innovative medicines franchise by 2030, driven by AUSTEDO, AJOVY, UZEDY, and a robust pipeline of late-stage assets including olanzapine LAI, duvakitug, DARI, and emrusolmin.
AUSTEDO: Expected to exceed $2.5 billion in sales by 2027 and exceed $3 billion by 2030.
AJOVY: A globally established brand with presence across 43 countries and expected launches in 3 additional countries this year.
LAI schizophrenia franchise expected to have $1.5 billion to $2.0 billion in peak sales
UZEDY: Fastest growing LAI with >60% risperidone LAI market share captured.
Olanzapine LAI: Set to expand our LAI franchise - U.S. NDA filing expected in H2 2025.
Stepping Up Innovation
Teva’s late-stage pipeline includes multiple assets with proven mechanisms and blockbuster potential:
duvakitug (anti-TL1A): A potentially best-in-class treatment for inflammatory bowel disease, with potential expansion into additional indications with peak sales potential of up to $2-$5 billion.
DARI: A dual-action rescue inhaler for asthma, that could address a significant unmet need as a first ICS/SABA combination for both adult and pediatric patient populations, with peak sales potential of ~$1 billion.
olanzapine LAI: A differentiated long-acting injectable for schizophrenia, that we expect to build on the success of UZEDY and expand Teva’s LAI franchise.
emrusolmin: A potential first-in-class treatment for Multiple System Atrophy (MSA), a rare and fatal neurodegenerative disease that currently has no approved treatments, with peak sales potential of more than $2 billion.
TEV-‘408: Anti-IL-15 antibody granted fast-track designation by the U.S. Food and Drug Administration (FDA) to be evaluated for the treatment of celiac disease, with peak sales potential of more than $1 billion.
Sustaining Our Generics Powerhouse
Teva’s generics, biosimilars, and OTC business remains a stable, robust and cash-generating powerhouse. Teva continues to lead in generics globally, with a strong pipeline of complex generics and biosimilars.
13 biosimilars in the pipeline, with potential for 5 new launches planned by 2027.
Strategic focus on complex generics, biosimilars, and OTC to compensate gRevlimid by 2027.
Expanding on our $1.1 billion OTC business with a global portfolio of strong local and global brands, outperforming the market with double-digit growth.
Continued manufacturing transformation to enhance competitiveness and margins.
Focusing Our Business
Teva is accelerating shareholder value creation with reaffirmed its 2027 financial targets:
Revenue growth driven by innovative launches and stable generics business.
Operating margin expansion to 30% by 2027.
Free cash flow of >$2.7 billion in 2027 and >$3.5 billion by 2030.
Payment of debt down to 2x net leverage.
~$700 million in net savings through modernizing the organization and improving operational efficiencies, enabling reinvestment in R&D and commercial capabilities.
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