Submission is supported by 48-week results from the Phase 3
GALAXI and GRAVITI programs
TREMFYA® is the only IL-23 inhibitor to
demonstrate strong endoscopic outcomes with subcutaneous (SC)
induction, consistent with intravenous (IV) induction, and has the
potential to be the first in its class to offer the option of both
SC and IV induction therapy in Crohn's disease
GALAXI includes data demonstrating superior outcomes for
TREMFYA® versus STELARA® (ustekinumab) in
Crohn's disease
SPRING
HOUSE, Pa., June 20,
2024 /PRNewswire/ -- Johnson & Johnson (NYSE:
JNJ) today announced the submission of a supplemental Biologics
License Application (sBLA) to the U.S. Food and Drug Administration
(FDA) seeking approval of TREMFYA® (guselkumab) for the
treatment of adults with moderately to severely active Crohn's
disease. This marks the second submission to the FDA for
TREMFYA® in inflammatory bowel disease this year
following an application in March for moderately to severely active
ulcerative colitis.a
The latest submission includes results from the Phase 3 GALAXI
program,1 which was featured as a late-breaking
oral presentation at Digestive Disease Week (DDW) 2024 last
month.2 The GALAXI 2 and GALAXI 3 studies were the
first-ever double-blind registrational head-to-head trials to
demonstrate superiority versus ustekinumab in Crohn's
disease.2 TREMFYA® successfully met the
co-primary endpoints for both SC maintenance doses (200 mg every 4
weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in
each individual study and demonstrated superiority to ustekinumab
in multiplicity-controlled endoscopic endpoints based on data
pooled from both studies.2
The submission also includes results from the Phase 3 GRAVITI
investigational study of TREMFYA ® SC
induction therapy in adult patients with moderately to severely
active Crohn's disease,3 which met the co-primary
endpoints, achieving statistically significant and clinically
meaningful outcomes for clinical remission at Week 12 as well as
endoscopic response at Week 12. In addition, all
multiplicity-controlled endpoints were met compared to placebo at
Week 12, Week 24 and Week 48.4 The results from GALAXI
and GRAVITI show that TREMFYA® has the potential to
become the only IL-23 inhibitor to offer both subcutaneous or
intravenous induction options for the treatment of Crohn's disease,
and, if approved, will offer choice and versatility for patients
and providers.2,4
"Building upon nearly three decades of leadership and innovation
in immunology, we are committed to addressing the needs of people
living with Crohn's disease through deep, scientific expertise and
through our continued pioneering advances in the IL-23 pathway,"
said David Lee, M.D., Ph.D., Global
Therapeutic Area Head Immunology, Johnson & Johnson Innovative
Medicine. "TREMFYA has the potential to be a differentiated
treatment option for patients who seek symptom relief and sustained
remission. We look forward to working with the Agency in their
review of the data supporting the application as we continue to
innovate for people living with inflammatory bowel disease."
TREMFYA® is the first approved fully-human,
dual-acting monoclonal antibody that blocks IL-23 while also
binding to CD64, a receptor on cells that produce
IL-23.5 IL-23 is a cytokine secreted by activated
monocyte/macrophages and dendritic cells that is known to be a
driver of immune-mediated diseases including Crohn's
disease.6 TREMFYA®, the first-in-class IL-23
inhibitor, received U.S. FDA approval in July 2017 for the treatment of adult patients
with moderate-to-severe plaque psoriasis and was subsequently
approved for adults with active psoriatic arthritis in July 2020.5
Janssen-Cilag International NV, a Johnson & Johnson company,
previously announced the submission of applications to the
European Medicines Agency (EMA) seeking to expand the Marketing
Authorization Application for TREMFYA® to include the
treatment of adult patients with moderately to severely active
ulcerative colitis and moderately to severely active Crohn's
disease.
Editor's Notes:
a. TREMFYA® is not approved to
treat ulcerative colitis or Crohn's disease.
ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled,
active-controlled (ustekinumab), global, multicenter Phase 2/3
program designed to evaluate the efficacy and safety of guselkumab
in participants with moderately to severely active Crohn's disease
with inadequate response/intolerance to conventional therapies
(corticosteroids or immunomodulators) and/or biologics (TNF
antagonists or vedolizumab).1 GALAXI includes a Phase 2
dose-ranging study (GALAXI 1) and two independent, identically
designed confirmatory Phase 3 studies (GALAXI 2 and 3).1
Each GALAXI study employed a treat-through design in which
participants remained on the treatment to which they were initially
randomized and includes a long-term extension study that will
assess clinical, endoscopic, and safety outcomes with guselkumab
through a total of five years. Participants randomized to placebo
were able to receive ustekinumab if clinical response was not met
at Week 12. 1
ABOUT THE GRAVITI PROGRAM (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase
3 study to evaluate guselkumab SC induction therapy (400 mg at
Weeks 0, 4, and 8) in patients with moderately to severely active
Crohn's disease who experienced an inadequate response or failed to
tolerate conventional therapy (i.e., corticosteroids or
immunomodulators) or biologic therapy (TNF antagonists or
vedolizumab).3 The maintenance doses in GRAVITI are the
same as those evaluated in GALAXI (200 mg SC q4w and 100 mg SC
q8w).3 The study employed a treat-through design, in
which patients are randomized to guselkumab at Week 0 and remain on
that regimen throughout the study, regardless of clinical response
status at the end of induction.3 Participants randomized
to placebo were able to receive guselkumab (400 mg SC q4w x3
➔ 100 mg SC q8w) if rescue criteria were met at Week
16.3
ABOUT CROHN'S DISEASE
Crohn's disease is one of the two main forms of inflammatory
bowel disease, which affects an estimated three million Americans
and an estimated four million people across Europe.7,8 Crohn's disease is
a chronic inflammatory condition of the gastrointestinal tract with
no known cause, but the disease is associated with abnormalities of
the immune system that could be triggered by a genetic
predisposition, diet, or other environmental
factors.9 Symptoms of Crohn's disease can vary, but
often include abdominal pain and tenderness, frequent diarrhea,
rectal bleeding, weight loss, and fever. Currently no cure is
available for Crohn's disease.10
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is
the first approved fully-human, dual-acting monoclonal antibody
that blocks IL-23 by binding to the p19 subunit of IL-23 and
binding to CD64, a receptor on cells that produce
IL-23.3 IL-23 is an important driver of the
pathogenesis of inflammatory diseases.5 Findings
for dual-acting are limited to in vitro studies that demonstrate
guselkumab binds to CD64, which is expressed on the surface of
IL-23 producing cells in an inflammatory monocyte model. The
clinical significance of this finding is not
known.11,12,13,14
TREMFYA® is approved in the
U.S.,5 Canada,15 Japan16 and
a number of other countries for the treatment of adults with
moderate-to-severe plaque psoriasis (PsO) who are candidates for
injections or pills (systemic therapy) or phototherapy (treatment
using ultraviolet light) and for the treatment of adult patients
with active psoriatic arthritis (PsA).17 It is also
approved in the EU for the treatment of moderate-to-severe plaque
PsO in adults who are candidates for systemic therapy and for the
treatment of active PsA in adult patients who have had an
inadequate response or who have been intolerant to a prior
disease-modifying antirheumatic drug therapy.17
Johnson & Johnson maintains exclusive worldwide
marketing rights to TREMFYA®.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
TREMFYA® (guselkumab)?
TREMFYA® is a prescription medicine that may
cause serious side effects, including:
- Serious Allergic Reactions. Stop using
TREMFYA® and get emergency medical help right away if
you develop 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 tightness
- chest tightness
- skin rash, hives
- itching
- Infections. TREMFYA® 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
TREMFYA® and may treat you for TB before you begin
treatment with TREMFYA® 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 TREMFYA®.
Tell your healthcare provider right away if you have an infection
or have symptoms of an infection, including:
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than
normal
Do not use TREMFYA® if you have had a
serious allergic reaction to guselkumab or any of the ingredients
in TREMFYA®.
Before using TREMFYA®, 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 TREMFYA®?"
- 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). You should avoid receiving live vaccines
during treatment with TREMFYA®.
- are pregnant or plan to become pregnant. It is not known if
TREMFYA® can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
TREMFYA® passes into your breast milk.
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
TREMFYA®?
TREMFYA® may cause serious side effects. See
"What is the most important information I should know about
TREMFYA®?"
The most common side effects of
TREMFYA® include: upper respiratory
infections, headache, injection site reactions, joint pain
(arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin
infections, herpes simplex infections, and bronchitis.
These are not all the possible side effects of
TREMFYA®. Call your doctor for medical advice about side
effects.
Use TREMFYA® exactly as your healthcare provider
tells you to use it.
Please read the full Prescribing Information,
including Medication Guide for
TREMFYA®, and discuss any questions that you have with
your doctor.
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.
ABOUT STELARA® (ustekinumab)
STELARA® (ustekinumab), a human interleukin (IL)-12
and IL-23 antagonist, is approved in the
United States for the treatment of: 1) adults and children
six years and older with moderate to severe plaque psoriasis who
are candidates for phototherapy or systemic therapy; 2) adults and
children six years and older with active psoriatic arthritis; 3)
adult patients (18 years and older) with moderately to severely
active Crohn's disease; 4) adult patients (18 years and older) with
moderately to severely active ulcerative colitis.18
The Janssen Pharmaceutical Companies of Johnson &
Johnson maintain exclusive worldwide marketing rights to
STELARA®.
IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that affects
your immune system. STELARA® can increase your
chance of having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight
infections and may increase your risk of infections. While taking
STELARA®, some people have serious infections, which may
require hospitalization, including tuberculosis (TB), and
infections caused by bacteria, fungi, or viruses.
- Your doctor should check you for TB before starting
STELARA® and watch you closely for signs and
symptoms of TB during treatment with STELARA®.
- If your doctor feels that you are at risk for TB, you may be
treated for TB before and during treatment with
STELARA®.
You should not start taking STELARA® if you have
any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if
you:
- think you have an infection or have symptoms of an infection
such as:
- fever, sweats, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open cuts.
- get a lot of infections or have infections that keep coming
back.
- have TB, or have been in close contact with someone with
TB.
After starting STELARA®, call your doctor right
away if you have any symptoms of an infection (see
above). These may be signs of infections such as chest infections,
or skin infections or shingles that could have serious
complications. STELARA® can make you more likely to
get infections or make an infection that you have worse. People who
have a genetic problem where the body does not make any of the
proteins interleukin 12 (IL–12) and interleukin 23 (IL–23) are at a
higher risk for certain serious infections that can spread
throughout the body and cause death. People who take
STELARA® may also be more likely to get these
infections.
Cancers
STELARA® may decrease the activity of your
immune system and increase your risk for certain types of cancer.
Tell your doctor if you have ever had any type of cancer. Some
people who had risk factors for skin cancer developed certain types
of skin cancers while receiving STELARA®. Tell your
doctor if you have any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES is a rare condition that affects the brain and can cause
death. The cause of PRES is not known. If PRES is found early and
treated, most people recover. Tell your doctor right away if you
have any new or worsening medical problems including: headache,
seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using
STELARA® and get medical help right away if you
have any symptoms of a serious allergic reaction such as: feeling
faint, swelling of your face, eyelids, tongue, or throat, chest
tightness, or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who
receive STELARA® and may be serious. These lung
problems may need to be treated in a hospital. Tell your doctor
right away if you develop shortness of breath or a cough that
doesn't go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about
all of your medical conditions, including if you:
- have any of the conditions or symptoms listed above for serious
infections, cancers, or PRES.
- ever had an allergic reaction to STELARA® or
any of its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled
syringe contains latex.
- have recently received or are scheduled to receive an
immunization (vaccine). People who take
STELARA® should not receive live vaccines. Tell
your doctor if anyone in your house needs a live vaccine. The
viruses used in some types of live vaccines can spread to people
with a weakened immune system, and can cause serious
problems. You should not receive the BCG vaccine during the
one year before receiving STELARA® or one year
after you stop receiving STELARA®.
- have any new or changing lesions within psoriasis areas or on
normal skin.
- are receiving or have received allergy shots, especially for
serious allergic reactions.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if
STELARA® can harm your unborn baby. You and
your doctor should decide if you will receive
STELARA® if you are breastfeeding or plan to
breastfeed. It is thought that
STELARA® passes into your breast milk.
- talk to your doctor about the best way to feed your baby if you
receive STELARA®.
Tell your doctor about all the medicines you take,
including prescription and over–the–counter medicines, vitamins,
and herbal supplements. Know the medicines you take. Keep a list of
them to show your doctor and pharmacist when you get a new
medicine.
When prescribed STELARA®:
- Use STELARA® exactly as your doctor tells you
to.
- STELARA® is intended for use under the guidance
and supervision of your
doctor. In children 6 years and older, it is recommended that
STELARA® be administered by a healthcare provider.
If your doctor decides that you or a caregiver may give your
injections of STELARA® at home, you should receive
training on the right way to prepare and inject
STELARA®. Your doctor will determine the right dose of
STELARA® for you, the amount for each injection,
and how often you should receive it. Do not try to inject
STELARA® yourself until you or your caregiver have
been shown how to inject STELARA® by your doctor or
nurse.
Common side effects of
STELARA® include: nasal congestion, sore
throat, and runny nose, upper respiratory infections, fever,
headache, tiredness, itching, nausea and vomiting, redness at the
injection site, vaginal yeast infections, urinary tract infections,
sinus infection, bronchitis, diarrhea, stomach pain, and joint
pain. These are not all of the possible side effects with
STELARA®. Tell your doctor about any side effect that
you experience. Ask your doctor or pharmacist for more
information.
Please click to read the full Prescribing
Information and Medication Guide for
STELARA® and discuss any questions you have with
your doctor.
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.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build
a world where complex diseases are prevented, treated, and
cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in
Innovative Medicine and MedTech, we are uniquely positioned to
innovate across the full spectrum of healthcare solutions today to
deliver the breakthroughs of tomorrow, and profoundly impact health
for humanity. Learn more at https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us at
@JNJInnovMed. Janssen Research & Development, LLC, Janssen
Biotech, Inc. and Janssen-Cilag International NV are Johnson &
Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding TREMFYA®. The reader is cautioned not to rely
on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Janssen Research & Development,
LLC, Janssen Biotech, Inc., Janssen-Cilag International
NV and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to: challenges and uncertainties inherent in
product research and development, including the uncertainty of
clinical success and of obtaining regulatory approvals; uncertainty
of commercial success; manufacturing difficulties and delays;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; product
efficacy or safety concerns resulting in product recalls or
regulatory action; changes in behavior and spending patterns of
purchasers of health care products and services; changes to
applicable laws and regulations, including global health care
reforms; and trends toward health care cost containment. A further
list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended December
31, 2023, including in the sections captioned "Cautionary
Note Regarding Forward-Looking Statements" and "Item 1A. Risk
Factors," and in Johnson & Johnson's subsequent Quarterly
Reports on Form 10-Q and other filings with the Securities and
Exchange Commission. Copies of these filings are available online
at www.sec.gov, www.jnj.com or on request from Johnson &
Johnson. None of Janssen Research & Development, LLC, Janssen
Biotech, Inc., Janssen-Cilag International NV nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
- National Institutes of Health: Clinicaltrials.gov. A study
of the efficacy and safety of guselkumab in participants with
moderately to severely active Crohn's disease (GALAXI). Identifier:
NCT03466411. Available at:
https://clinicaltrials.gov/study/NCT03466411. Accessed June 2024.
- Panaccione, R et al. Efficacy and safety of guselkumab therapy
in patients with moderately to severely active Crohn's disease:
results of the GALAXI 2 & 3 Phase 3 studies. Oral presentation
(Abstract #1057b) at Digestive Disease Week (DDW) 2024.
May 2024.
- National Institutes of Health: Clinicaltrials.gov. A study
of guselkumab subcutaneous therapy in participants with moderately
to severely active Crohn's disease (GRAVITI). Identifier:
NCT05197049. Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT05197049. Accessed
June 2024.
- Data on file. Guselkumab. Clinical study report
CNTO1959CRD3004 (GRAVITI).
- US Food and Drug Administration. TREMFYA®
prescribing information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf.
Accessed June 2024.
- Schinocca, C. et al. Role of the IL-23/IL-17 pathway in
rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb
22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829.
Accessed June 2024.
- Crohn's & Colitis Foundation. Overview of Crohn's disease.
Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview.
Accessed June 2024.
- Ng SC, et al. Worldwide incidence and prevalence of
inflammatory bowel disease in the 21st century: a systematic review
of population-based studies. The Lancet. 2017;390:2769-78.
- Crohn's & Colitis Foundation. What is Crohn's disease?
Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes.
Accessed June 2024.
- Crohn's & Colitis Foundation. Signs and symptoms of Crohn's
disease. Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms.
Accessed June 2024.
- Mehta H, et al. Differential changes in inflammatory
mononuclear phagocyte and T-Cell profiles within psoriatic skin
during treatment with guselkumab vs. secukinumab. J Invest Dermatol
2021;141(7):1707-1718. Available at:
https://pubmed.ncbi.nlm.nih.gov/33524368/. Accessed June 2024.
- Wang Y, et al. Monocytes/Macrophages play a pathogenic
role in IL-23 mediated psoriasis-like skin inflammation. Sci Rep.
2019;9(1):5310. Available at:
https://pubmed.ncbi.nlm.nih.gov/30926837/. Accessed June 2024.
- Matt P, et al. Up-regulation of CD64-expressing monocytes
with impaired FcγR function reflects disease activity in
polyarticular psoriatic arthritis. Scand J Rheumatol 2015;
44(6):464-473. Available at:
https://pubmed.ncbi.nlm.nih.gov/26084203/. Accessed June 2024.
- McGonagle D, et al. Guselkumab, an IL-23p19 subunit–specific
monoclonal antibody, binds CD64+ myeloid cells and potently
neutralises IL-23 produced from the same cells. Presented at EULAR
2023, May 31-June 3.
- The Canadian Agency for Drugs & Technologies in
Health. TREMFYA® prescribing information. Available
at: https://www.cadth.ca/guselkumab-0. Accessed June 2024.
- Japan Pharmaceuticals and Medical Devices Agency. Tremfya
report on the deliberation results. Available at:
https://www.pmda.go.jp/files/000234741.pdf. Accessed June 2024.
- European Commission: Tremfya (guselkumab). Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya. Accessed
June 2024.
- US Food and Drug Administration. STELARA®
prescribing information. Available at:
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf.
Accessed June 2024.
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