Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA® (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis
Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application (sBLA) to the FDA for TREMFYA® (guselkumab) seeking to include new evidence of joint structural damage inhibition in active psoriatic arthritis (PsA) patients.
The submission is supported by the Phase 3b APEX study, which achieved its primary endpoint of reducing joint symptoms (ACR20) and secondary endpoint of inhibiting structural damage progression at 24 weeks. TREMFYA® would become the first and only IL-23 inhibitor proven to both control symptoms and significantly inhibit joint damage progression in active PsA.
As a dual-acting monoclonal antibody, TREMFYA® uniquely blocks IL-23 while binding to CD64, demonstrating a well-established safety profile in the study.
Johnson & Johnson (NYSE:JNJ) ha presentato una domanda supplementare di Licenza Biologica (sBLA) alla FDA per TREMFYA® (guselkumab), con l'obiettivo di includere nuove evidenze sull'inibizione del danno strutturale articolare nei pazienti con artrite psoriasica (PsA) attiva.
La richiesta è supportata dallo studio di fase 3b APEX, che ha raggiunto il suo endpoint primario di riduzione dei sintomi articolari (ACR20) e l'endpoint secondario di inibizione della progressione del danno strutturale a 24 settimane. TREMFYA® diventerebbe il primo e unico inibitore dell'IL-23 dimostrato capace sia di controllare i sintomi sia di inibire significativamente la progressione del danno articolare nella PsA attiva.
Come anticorpo monoclonale a doppia azione, TREMFYA® blocca in modo unico l'IL-23 legandosi al CD64, mostrando un profilo di sicurezza ben consolidato nello studio.
Johnson & Johnson (NYSE:JNJ) ha presentado una solicitud suplementaria de Licencia Biológica (sBLA) a la FDA para TREMFYA® (guselkumab), buscando incluir nuevas evidencias de inhibición del daño estructural articular en pacientes con artritis psoriásica (PsA) activa.
La presentación está respaldada por el estudio de fase 3b APEX, que alcanzó su objetivo primario de reducir los síntomas articulares (ACR20) y el objetivo secundario de inhibir la progresión del daño estructural a las 24 semanas. TREMFYA® se convertiría en el primer y único inhibidor de IL-23 probado para controlar los síntomas y inhibir significativamente la progresión del daño articular en PsA activa.
Como un anticuerpo monoclonal de acción dual, TREMFYA® bloquea de manera única la IL-23 mientras se une a CD64, demostrando un perfil de seguridad bien establecido en el estudio.
Johnson & Johnson (NYSE:JNJ)는 활성 건선 관절염(PsA) 환자의 관절 구조 손상 억제에 대한 새로운 증거를 포함하기 위해 TREMFYA®(구셀쿠맙)에 대한 보충 생물학적 허가 신청서(sBLA)를 FDA에 제출했습니다.
이 제출은 주요 관절 증상 감소(ACR20)와 24주차 구조적 손상 진행 억제라는 2차 목표를 달성한 3상b APEX 연구에 의해 뒷받침됩니다. TREMFYA®는 활성 PsA에서 증상을 조절하고 관절 손상 진행을 유의미하게 억제하는 것으로 입증된 최초이자 유일한 IL-23 억제제가 될 것입니다.
이중 작용 단클론 항체인 TREMFYA®는 IL-23을 차단하는 동시에 CD64에 결합하여 연구에서 잘 확립된 안전성 프로필을 보여줍니다.
Johnson & Johnson (NYSE:JNJ) a soumis une demande complémentaire de licence biologique (sBLA) à la FDA pour TREMFYA® (guselkumab) visant à inclure de nouvelles preuves d'inhibition des lésions structurelles articulaires chez les patients atteints d'arthrite psoriasique (PsA) active.
Cette soumission est soutenue par l'étude de phase 3b APEX, qui a atteint son critère d'évaluation principal de réduction des symptômes articulaires (ACR20) et son critère secondaire d'inhibition de la progression des lésions structurelles à 24 semaines. TREMFYA® deviendrait le premier et unique inhibiteur de l'IL-23 prouvé capable à la fois de contrôler les symptômes et d'inhiber significativement la progression des lésions articulaires dans la PsA active.
En tant qu'anticorps monoclonal à double action, TREMFYA® bloque de manière unique l'IL-23 tout en se liant au CD64, démontrant un profil de sécurité bien établi dans l'étude.
Johnson & Johnson (NYSE:JNJ) hat einen ergänzenden Antrag auf Zulassung eines Biologikums (sBLA) bei der FDA für TREMFYA® (Guselkumab) eingereicht, um neue Nachweise zur Hemmung von Gelenkstruktur-Schäden bei Patienten mit aktiver psoriatischer Arthritis (PsA) einzubeziehen.
Die Einreichung wird durch die Phase-3b-Studie APEX unterstützt, die ihr primäres Ziel der Reduktion von Gelenksymptomen (ACR20) und ihr sekundäres Ziel der Hemmung des Fortschreitens struktureller Schäden nach 24 Wochen erreicht hat. TREMFYA® wäre der erste und einzige IL-23-Inhibitor, der sowohl die Symptome kontrolliert als auch die Gelenkschädigung bei aktiver PsA signifikant hemmt.
Als dual wirkender monoklonaler Antikörper blockiert TREMFYA® einzigartig IL-23 und bindet an CD64, wobei es in der Studie ein gut etabliertes Sicherheitsprofil zeigt.
- First and only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in PsA
- Achieved both primary endpoint (ACR20) and major secondary endpoint in Phase 3b APEX study
- Demonstrated well-established safety profile
- Unique dual-acting mechanism blocking IL-23 and binding to CD64
- None.
Insights
J&J's FDA filing could position TREMFYA as the only IL-23 inhibitor proven to inhibit joint structural damage in psoriatic arthritis.
Johnson & Johnson's supplemental Biologics License Application (sBLA) for TREMFYA® represents a significant potential advancement in the psoriatic arthritis treatment landscape. The submission is based on compelling data from the Phase 3b APEX study, which demonstrated that TREMFYA achieved both its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting structural damage progression at 24 weeks compared to placebo.
What makes this filing particularly noteworthy is that if approved, TREMFYA would become the first and only IL-23 inhibitor with proven ability to inhibit joint structural damage progression in psoriatic arthritis. This is clinically meaningful because joint damage in PsA can be irreversible, leading to permanent disability if not adequately controlled.
TREMFYA's dual mechanism of action - blocking IL-23 while binding to CD64 (a receptor on IL-23-producing cells) - provides a targeted approach to interrupting the inflammatory cascade in psoriatic arthritis. This mechanistic advantage may explain its efficacy in both symptom control and structural damage inhibition.
From a competitive standpoint, this label expansion would differentiate TREMFYA from other IL-23 inhibitors in the psoriatic arthritis market, potentially strengthening J&J's position in the immunology space where competition is intense. The consistent safety profile observed in the APEX study further supports TREMFYA's favorable risk-benefit profile for long-term management of this chronic condition.
Submission is supported by 24-week results from the Phase 3b APEX study in adults with active psoriatic arthritis treated with TREMFYA®, the only dual-acting IL-23 inhibitor
The submission is supported by the Phase 3b APEX study in patients with active PsA, which achieved both its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibited progression of structural damage as measured by change in the modified van der Heijde-Sharp (vdH-S) score at 24 weeks, compared to placebo in bio-naïve patients. These data were recently presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.
"Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition," said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. "With this new evidence, TREMFYA® would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA."
Data from the APEX study were consistent with the well-established safety profile of TREMFYA®. Additional data will be presented at future medical meetings.
TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA 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 active PsA.
Editor's Notes:
a) ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.
ABOUT THE APEX STUDY (NCT04882098)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO). The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age. Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale. In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present. Studies show up to
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 cells 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.
- adults with moderately to severely active Crohn's disease.
TREMFYA® is approved in
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:
- 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
- Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
- unexplained rash
- vomiting
- tiredness (fatigue)
- yellowing of the skin or the whites of your eyes
- nausea
- stomach pain (abdominal)
- loss of appetite
- dark urine
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.
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, stomach pain, 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 as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as 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.innovativemedicine.jnj.com.
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC, Janssen Scientific Affairs, 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 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 most recent Annual Report on Form 10-K, 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media contact: | Investor contact: | |
Britt | Lauren Johnson | |
267-449-6618 | ||
View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-files-with-us-fda-to-include-new-evidence-in-tremfya-guselkumab-label-as-the-only-il-23-inhibitor-to-demonstrate-significant-inhibition-of-joint-structural-damage-in-active-psoriatic-arthritis-302516055.html
SOURCE Johnson & Johnson
FAQ
What are the key findings of Johnson & Johnson's TREMFYA Phase 3b APEX study for psoriatic arthritis?
How does TREMFYA (guselkumab) work differently from other psoriatic arthritis treatments?
What is the significance of JNJ's new sBLA submission for TREMFYA?
What was the safety profile of TREMFYA in the APEX study?
When did Johnson & Johnson present the TREMFYA APEX study results?
