Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor
Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the FDA for a subcutaneous induction regimen of TREMFYA® to treat adults with moderately to severely active ulcerative colitis (UC). The submission is backed by the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at Week 12 and all secondary endpoints. The study demonstrated significant results with a 400 mg subcutaneous induction dose administered at Weeks 0, 4, and 8. If approved, TREMFYA® would be the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for UC treatment.
Johnson & Johnson (NYSE: JNJ) ha presentato una domanda supplementare di licenza biologica (sBLA) alla FDA per un regime di induzione sottocutanea di TREMFYA® per trattare adulti con colite ulcerosa (UC) da moderata a grave. La presentazione è supportata dallo studio di Fase 3 ASTRO, che ha raggiunto il suo obiettivo primario di remissione clinica alla Settimana 12 e tutti gli obiettivi secondari. Lo studio ha dimostrato risultati significativi con una dose di induzione sottocutanea di 400 mg somministrata alle Settimane 0, 4 e 8. Se approvato, TREMFYA® sarebbe il primo inibitore dell'IL-23 a offrire sia opzioni di induzione sottocutanea che endovenosa per il trattamento della UC.
Johnson & Johnson (NYSE: JNJ) ha presentado una solicitud suplementaria de licencia biológica (sBLA) a la FDA para un régimen de inducción subcutánea de TREMFYA® para tratar a adultos con colitis ulcerosa (UC) de moderada a grave. La solicitud cuenta con el respaldo del estudio de Fase 3 ASTRO, que cumplió con su objetivo primario de remisión clínica a las 12 semanas y todos los objetivos secundarios. El estudio demostró resultados significativos con una dosis de inducción subcutánea de 400 mg administrada en las Semanas 0, 4 y 8. Si se aprueba, TREMFYA® sería el primer inhibidor de IL-23 que ofrece tanto opciones de inducción subcutánea como intravenosa para el tratamiento de la UC.
존슨 앤드 존슨 (NYSE: JNJ)은 TREMFYA®의 피하 유도 요법에 대한 보충 생물학적 제품 허가 신청(sBLA)을 FDA에 제출했습니다. 이 치료는 중증의 활성 궤양성 대장염(UC)을 앓고 있는 성인을 대상으로 합니다. 이번 신청은 12주차에 임상 관해라는 주요 목표와 모든 2차 목표를 달성한 3상 ASTRO 연구에 기반하고 있습니다. 연구는 0주, 4주 및 8주에 400mg의 피하 유도 용량을 투여하여 상당한 결과를 나타냈습니다. 승인을 받을 경우, TREMFYA®는 UC 치료를 위한 피하 및 정맥 유도 옵션을 모두 제공하는 첫 번째 IL-23 억제제가 될 것입니다.
Johnson & Johnson (NYSE: JNJ) a soumis une demande de licence biologique supplémentaire (sBLA) à la FDA pour un régime d'induction sous-cutanée de TREMFYA® destiné à traiter les adultes souffrant de colite ulcéreuse (UC) d'activité modérée à sévère. La soumission est soutenue par l'étude de phase 3 ASTRO, qui a atteint son objectif principal de rémission clinique à la semaine 12 ainsi que tous les objectifs secondaires. L'étude a démontré des résultats significatifs avec une dose d'induction sous-cutanée de 400 mg administrée aux semaines 0, 4 et 8. Si elle est approuvée, TREMFYA® serait le premier inhibiteur de l'IL-23 à offrir des options d'induction à la fois sous-cutanées et intraveineuses pour le traitement de l'UC.
Johnson & Johnson (NYSE: JNJ) hat einen ergänzenden Antrag auf Biologika-Zulassungsantrag (sBLA) bei der FDA für ein subkutanes Induktionsschema von TREMFYA® zur Behandlung von Erwachsenen mit mäßig bis stark aktiver Kolitis ulcerosa (UC) eingereicht. Der Antrag wird durch die Phase-3-Studie ASTRO unterstützt, die das primäre Ziel der klinischen Remission nach 12 Wochen und alle sekundären Endpunkte erreicht hat. Die Studie zeigte signifikante Ergebnisse mit einer subkutanen Induktionsdosis von 400 mg, die in den Wochen 0, 4 und 8 verabreicht wurde. Wenn genehmigt, wäre TREMFYA® der erste IL-23-Hemmer, der sowohl subkutane als auch intravenöse Induktionsoptionen zur Behandlung von UC anbietet.
- Phase 3 ASTRO study met primary endpoint and all secondary endpoints
- Potential to be the first IL-23 inhibitor with both subcutaneous and intravenous induction options
- Safety data consistent with existing QUASAR program findings
- Recent FDA approval for UC treatment already secured (September 2024)
- Additional applications submitted for Crohn's disease in US and both CD/UC in Europe
- None.
Insights
This FDA submission for TREMFYA's subcutaneous induction regimen represents a significant advancement in ulcerative colitis treatment. The Phase 3 ASTRO study demonstrated both clinical remission at Week 12 and met all secondary endpoints, validating the efficacy of the subcutaneous administration route. If approved, TREMFYA would become the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for UC patients.
The potential approval could drive market expansion through improved patient convenience and adherence. The subcutaneous option eliminates the need for hospital visits for intravenous administration, potentially reducing healthcare costs. The dual mechanism of action - blocking IL-23 while binding to CD64 - provides a unique therapeutic approach that could translate to better outcomes for treatment-resistant cases.
This development strengthens J&J's position in the competitive inflammatory bowel disease (IBD) market, estimated at
The dual administration options could help capture market share from existing treatments and potentially command premium pricing. This flexibility in treatment administration could drive adoption among both physicians and patients, potentially increasing TREMFYA's market penetration in the growing IBD therapeutics segment.
Following recent
Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC
The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at Week 12 with a 400 mg SC induction dose of TREMFYA® administered at Weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. Safety data from ASTRO were consistent with the safety findings from the QUASAR program. Results from the ASTRO study are planned for presentation at upcoming medical meetings.1
"With the ASTRO study in UC and the GRAVITI study in Crohn's disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers," stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients."
TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. 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 UC.2,3,4,5,6
TREMFYA® received
An application seeking approval of TREMFYA® for the treatment of adults with moderately to severely active CD has been submitted in the
ABOUT THE ASTRO STUDY (NCT05528510)
ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program that established the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8
ABOUT THE QUASAR PROGRAM (NCT04033445)
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.9
ABOUT THE GRAVITI STUDY (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults 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). Patients received TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn's disease).10
ABOUT ULCERATIVE COLITIS
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.11
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.12 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. Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.13
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). 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.
TREMFYA® is a prescription medicine approved in the
- adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
- adults with active psoriatic arthritis.
- adults with moderately to severely active ulcerative colitis.2
TREMFYA® is approved
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.
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:
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- 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:
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Do not take 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.
Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. - 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 respiratory tract 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.
Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.
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 https://www.innovativemedicine.jnj.com/. 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.
Media contact: +1 215-779-9396 | Investor contact: |
1 Data on file.
2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023;
3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217
4 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed October 2024.
5 Skyrizi® [Prescribing Information].
6 Omvoh™ [Prescribing Information].
7 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed October 2024.
8 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. https://clinicaltrials.gov/study/NCT05528510?term=astro&intr=guselkumab&rank=1. Accessed October 2024.
9 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. https://classic.clinicaltrials.gov/ct2/show/NCT04033445. Accessed October 2024.
10 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 October 2024.
11 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 2024.
12 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed October 2024.
13 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed October 2024.
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FAQ
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