TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease
Johnson & Johnson (NYSE: JNJ) announced FDA approval of TREMFYA® (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). TREMFYA® is the first dual-acting interleukin-23 inhibitor approved for UC, showing significant endoscopic remission rates at one year in the QUASAR program. Key findings include:
- 50% of patients on TREMFYA® 200 mg q4w and 45% on 100 mg q8w achieved clinical remission at week 44 vs 19% on placebo.
- 34% (200 mg) and 35% (100 mg) achieved endoscopic remission at one year vs 15% on placebo.
This approval marks TREMFYA®'s third indication, following plaque psoriasis and active psoriatic arthritis. The recommended dosage for UC is 200 mg induction dose at weeks 0, 4, and 8, followed by maintenance doses.
Johnson & Johnson (NYSE: JNJ) ha annunciato l'approvazione della FDA per TREMFYA® (guselkumab) nel trattamento degli adulti con colite ulcerosa (UC) moderatamente a severamente attiva. TREMFYA® è il primo inibitore duale dell'interleuchina-23 approvato per la UC, mostrando tassi significativi di remissione endoscopica a un anno nel programma QUASAR. I principali risultati includono:
- Il 50% dei pazienti trattati con TREMFYA® 200 mg ogni 4 settimane e il 45% di quelli con 100 mg ogni 8 settimane hanno raggiunto la remissione clinica alla settimana 44 rispetto al 19% in placebo.
- Il 34% (200 mg) e il 35% (100 mg) hanno raggiunto la remissione endoscopica dopo un anno rispetto al 15% in placebo.
Questa approvazione segna la terza indicazione per TREMFYA®, dopo la psoriasi a placche e l'artrite psoriasica attiva. La dose raccomandata per la UC è di 200 mg come dose di induzione alle settimane 0, 4 e 8, seguita da dosi di mantenimento.
Johnson & Johnson (NYSE: JNJ) anunció la aprobación de la FDA para TREMFYA® (guselkumab) en el tratamiento de adultos con colitis ulcerosa (CU) de moderada a severa. TREMFYA® es el primer inhibidor dual de interleucina-23 aprobado para CU, mostrando tasas significativas de remisión endoscópica al año en el programa QUASAR. Los hallazgos clave incluyen:
- El 50% de los pacientes en TREMFYA® 200 mg cada 4 semanas y el 45% en 100 mg cada 8 semanas lograron remisión clínica a la semana 44 frente al 19% en placebo.
- El 34% (200 mg) y el 35% (100 mg) lograron remisión endoscópica al año frente al 15% en placebo.
Esta aprobación marca la tercera indicación de TREMFYA®, después de la psoriasis en placas y la artritis psoriásica activa. La dosis recomendada para CU es de 200 mg como dosis de inducción en las semanas 0, 4 y 8, seguida de dosis de mantenimiento.
존슨앤드존슨 (NYSE: JNJ)는 TREMFYA® (구셀쿠맙)가 중등도에서 중증의 활성 궤양성 대장염 (UC) 치료를 위한 FDA 승인을 받았다고 발표했습니다. TREMFYA®는 UC에 대해 승인된 첫 번째 이중 작용 인터루킨-23 억제제로, QUASAR 프로그램에서 1년 동안 상당한 내시경적 관해율을 보였습니다. 주요 발견 사항은 다음과 같습니다:
- TREMFYA® 200 mg을 4주마다 투여받은 환자의 50%와 100 mg을 8주마다 투여받은 환자의 45%가 위약 그룹의 19%에 비해 44주차에 임상적 관해에 도달했습니다.
- 1년 후 34% (200 mg)와 35% (100 mg)가 위약의 15%에 비해 내시경적 관해에 도달했습니다.
이번 승인은 흉터성 건선 및 활성 건선 관절염에 이어 TREMFYA®의 세 번째 적응증을 나타냅니다. UC에 대한 권장 용량은 0주, 4주 및 8주에 200 mg의 유도 용량을 투여하고 유지 용량을 따릅니다.
Johnson & Johnson (NYSE: JNJ) a annoncé l'approbation par la FDA de TREMFYA® (guselkumab) pour le traitement des adultes atteints de colite ulcéreuse (CU) modérément à sévèrement active. TREMFYA® est le premier inhibiteur dual de l'interleukine-23 approuvé pour la CU, montrant des taux significatifs de rémission endoscopique à un an dans le programme QUASAR. Les principales conclusions comprennent :
- 50% des patients sous TREMFYA® 200 mg toutes les 4 semaines et 45% sous 100 mg toutes les 8 semaines ont atteint une rémission clinique à la semaine 44 contre 19% sous placebo.
- 34% (200 mg) et 35% (100 mg) ont atteint une rémission endoscopique à un an contre 15% sous placebo.
Cette approbation marque la troisième indication de TREMFYA®, après la psoriasis en plaques et l'arthrite psoriasique active. La posologie recommandée pour la CU est une dose d'induction de 200 mg aux semaines 0, 4 et 8, suivie de doses d'entretien.
Johnson & Johnson (NYSE: JNJ) gab die FDA-Zulassung für TREMFYA® (guselkumab) zur Behandlung von Erwachsenen mit mittelgradiger bis schwer aktiver Colitis ulcerosa (CU) bekannt. TREMFYA® ist der erste dual wirkende Interleukin-23-Hemmer, der für CU zugelassen ist und im QUASAR-Programm signifikante endoskopische Remissionsraten nach einem Jahr gezeigt hat. Wichtige Ergebnisse umfassen:
- 50% der Patienten, die TREMFYA® 200 mg alle 4 Wochen und 45% der Patienten, die 100 mg alle 8 Wochen erhielten, erreichten nach 44 Wochen eine klinische Remission im Vergleich zu 19% in der Placebo-Gruppe.
- 34% (200 mg) und 35% (100 mg) erreichten nach einem Jahr eine endoskopische Remission im Vergleich zu 15% in der Placebo-Gruppe.
Diese Zulassung markiert die dritte Indikation von TREMFYA®, nach Plaque-Psoriasis und aktiver psoriatischer Arthritis. Die empfohlene Dosierung für CU beträgt eine Induktionsdosis von 200 mg in den Wochen 0, 4 und 8, gefolgt von Erhaltungsdosen.
- FDA approval for TREMFYA® in treating ulcerative colitis, expanding its market
- High clinical remission rates: 50% (200 mg) and 45% (100 mg) vs 19% placebo at week 44
- Significant endoscopic remission rates: 34-35% vs 15% placebo at one year
- Third approved indication for TREMFYA®, strengthening J&J's immunology portfolio
- Potential for self-administration of maintenance doses, improving patient convenience
- None.
Insights
The FDA approval of TREMFYA® for ulcerative colitis (UC) is a significant milestone in inflammatory bowel disease treatment. The drug's dual-action mechanism, targeting both IL-23 and CD64, sets it apart from other treatments. Clinical data from the QUASAR study is particularly impressive, with
The approval for UC expands TREMFYA®'s indications, potentially increasing its market share and reinforcing J&J's position in immunology. However, it's important to monitor long-term safety data and real-world effectiveness as the drug's use expands to this new patient population.
This FDA approval strengthens Johnson & Johnson's position in the lucrative inflammatory bowel disease market. With TREMFYA® now approved for three indications (psoriasis, psoriatic arthritis and UC), J&J can leverage its existing infrastructure to potentially capture a significant share of the estimated
The expanded indication could drive revenue growth for TREMFYA®, which generated
TREMFYA®'s approval for UC represents a paradigm shift in treatment options. Its unique mechanism of action, targeting both IL-23 and CD64, addresses the underlying inflammation more comprehensively than existing therapies. The high rates of endoscopic remission are particularly noteworthy, as mucosal healing is associated with better long-term outcomes.
The flexible dosing options (100 mg q8w or 200 mg q4w) allow for personalized treatment. However, clinicians should be aware of potential side effects and monitor patients closely, especially during the induction phase. The drug's efficacy in patients who have failed other biologics or JAK inhibitors is promising, offering a new option for difficult-to-treat cases.
The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5
TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis
"Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining," said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine, and lead investigator for the QUASAR program. "Today's approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease."
The UC approval is supported by data from the pivotal, ongoing Phase 2b/3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors.6 Highlights from QUASAR showed:
50% of patients receiving TREMFYA® 200 mg subcutaneous (SC) maintenance every four weeks (q4w) and45% of patients receiving TREMFYA® 100 mg SC every eight weeks (q8w) achieved primary endpoint of clinical remission at week 44 compared to19% placebo-treated patients (p<0.001).34% (200 mg) and35% (100 mg) of patients achieved endoscopic remission at one year with TREMFYA® SC maintenance therapy compared to15% placebo-treated patients (p<0.001).
"There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission," said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. "In the QUASAR clinical program, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease."
For the treatment of UC, TREMFYA® is administered as a 200 mg induction dose intravenously at weeks zero, four and eight by a healthcare professional. The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter. The SC maintenance dose can be self-administered by the patient or administered by a caregiver using TREMFYA® after proper training. Use the lowest effective recommended dosage to maintain therapeutic response.
The QUASAR results reinforced the well-established safety profile of TREMFYA® including in the treatment of patients with UC. This FDA approval marks the third indication approved for TREMFYA®, which builds on Johnson & Johnson's nearly 30-year legacy of immunology innovation. TREMFYA® first received approval in the
Editor's Notes:
- CD64+ cells are the predominant source of IL-23 in UC. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.1,2
- "Only" based on approved selective IL-23 inhibitors for moderately to severely active UC as of September 2024.3,4,5
- Based on in vitro studies in an inflammatory monocyte model.1
- Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.6
- Endoscopic remission (normalization) was defined as a Mayo endoscopic subscore of 0.6
- Dr. Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
- TREMFYA® is not approved for the treatment of adults living with Crohn's disease in the
U.S.
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®, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor-alpha antagonists, vedolizumab, or tofacitinib).3 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.6
The most common adverse reactions (>
ABOUT ULCERATIVE COLITIS
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. It is the result of the immune system's overactive response. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.7 Patients with UC also have increased rates of depression.8 More than one million people in the
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 approved in the
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®?
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:
o fainting, dizziness, feeling lightheaded o swelling of your face, eyelids, lips, | o trouble breathing or throat tightness o chest tightness o skin rash, hives o 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:
o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your | o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often |
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 www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC. and Janssen Biotech, Inc. are all 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 Scientific Affairs, LLC. and Janssen Biotech, Inc. 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 Scientific Affairs, LLC. and Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 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;
2 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
3 TREMFYA® [Prescribing Information].
4 Skyrizi® [Prescribing Information].
5 OmvohTM [Prescribing Information].
6 Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. Accessed September 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04033445
7 Crohn's & Colitis Foundation. What is ulcerative colitis? Accessed September 2024. https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis
8 Yuan X, Chen B, Duan Z, et al. Depression and anxiety in patients with active ulcerative colitis: crosstalk of gut microbiota, metabolomics and proteomics. Gut Microbes. 2021;13(1):1987779. doi: 10.1080/19490976.2021.1987779
9 Lewis, JD, et al. Incidence, prevalence and racial and ethnic distribution of inflammatory bowel disease in
10 Shivashankar R, Tremaine WJ, Harmsen WS, et al. Incidence and prevalence of Crohn's disease and ulcerative colitis in
11 Le Berre C, Honap S, Peyrin-Biroulet L. Ulcerative colitis. Lancet. 2023;402(10401):571-584. doi: 10.1016/S0140-6736(23)00966-2
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FAQ
What is the new FDA approval for TREMFYA® (JNJ) announced on September 11, 2024?
What were the key efficacy results for TREMFYA® in the QUASAR study for ulcerative colitis?
What is the recommended dosage for TREMFYA® in treating ulcerative colitis?
How many indications does TREMFYA® (JNJ) now have following this FDA approval?
