Patients treated with subcutaneous TREMFYAachieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub- groups TREMFYA Â is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis , /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today anno ...

Accessibility StatementSkip Navigation TREMFYA is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA achieved high levels of skin clearance vs. placebo at Week 16 HORSHAM, Pa., Sept. 29, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) tod ...

Core Viewpoint - Johnson & Johnson (JNJ) has submitted a new drug application (NDA) to the FDA for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][9]. Group 1: Clinical Development and Efficacy - The NDA submission is based on data from four phase III studies, part of the ICONIC clinical development program, which evaluated icotrokinra as an IL-23 inhibitor for psoriasis and psoriatic arthritis [2]. - Icotrokinra met all primary and co-primary endpoints across the four pivotal studies, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing [3]. - The studies also showed icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu (deucravacitinib) [4][12]. Group 2: Market Position and Future Potential - JNJ's shares have increased by 13.7% this year, contrasting with a 2.1% decline in the industry [5]. - Management believes icotrokinra has the potential to transform the treatment landscape for plaque psoriasis and could establish itself as the new standard of care [6]. - Icotrokinra is designed to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases [7]. Group 3: Collaborative Development and Ongoing Studies - Icotrokinra is being developed in collaboration with Protagonist Therapeutics (PTGX), with JNJ holding exclusive worldwide rights for development beyond phase II studies [10]. - Positive results were reported from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in ulcerative colitis, meeting its primary endpoint [11]. - JNJ is conducting the phase III ICONIC-ASCEND study to compare icotrokinra with its own drug, Stelara (ustekinumab), aiming to provide a more convenient oral alternative [12].

Core Insights - TREMFYA® (guselkumab) demonstrated significant efficacy in inhibiting joint structural damage and improving symptoms in patients with active psoriatic arthritis (PsA) in the Phase 3b APEX study [1][2][3] Efficacy Results - TREMFYA® showed a 2.5 times greater ability to inhibit joint structural damage compared to placebo [1] - At Week 24, 67% of patients receiving TREMFYA® every four weeks (Q4W) and 63% every eight weeks (Q8W) experienced no radiographic progression, compared to 53% in the placebo group [2] - More than 40% of TREMFYA®-treated patients achieved ACR50 response at Week 24, significantly higher than the 20% in the placebo group [1][5] Safety Profile - The safety profile of TREMFYA® remained consistent with previous studies, with no new safety signals identified [3] - TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64 [3][9] Study Design - The APEX study was a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [7] Market Position - Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, which is approved in multiple regions for treating moderate-to-severe plaque psoriasis and active PsA [10][24]

Core Insights - Johnson & Johnson announced significant results from the Phase 3 ASTRO study, demonstrating that TREMFYA® (guselkumab) subcutaneous induction therapy leads to substantial clinical remission and endoscopic improvement in adults with moderately to severely active ulcerative colitis at Week 24 [1][2] Group 1: Study Findings - At Week 24, patients receiving TREMFYA® 400 mg SC induction followed by maintenance doses of 100 mg every eight weeks or 200 mg every four weeks showed statistically significant improvements in clinical remission (35.3% and 36.4% respectively) compared to placebo (9.4%) [2] - Symptomatic remission rates were 54.7% for the 100 mg q8w group and 50.0% for the 200 mg q4w group, compared to 25.2% for placebo [2] - Endoscopic improvement was observed in 40.3% of the 100 mg q8w group and 45.0% of the 200 mg q4w group, while only 12.2% of placebo patients experienced improvement [2] Group 2: Treatment Options and Flexibility - TREMFYA® is the first and only IL-23 inhibitor to show robust results with a fully subcutaneous regimen, providing greater flexibility for physicians and patients in treatment approaches [1][2] - The availability of both subcutaneous and intravenous induction options allows for a more tailored treatment plan for patients with ulcerative colitis [2] Group 3: Safety and Efficacy - Safety data from the ASTRO study were consistent with the established safety profile of TREMFYA®, indicating a favorable risk-benefit ratio [2] - The study included a diverse patient population, demonstrating significant results across various subpopulations, including those who were biologic and JAK inhibitor-naïve or refractory [2] Group 4: Regulatory Approvals - TREMFYA® received FDA approval in September 2024 for treating adults with moderately to severely active ulcerative colitis, with a supplemental Biologics License Application submitted for the SC induction regimen [2] - The drug was also approved for both SC and IV induction options for Crohn's disease in March 2025, expanding its therapeutic applications [2]

Core Insights - TREMFYA® (guselkumab) has shown clinically meaningful and statistically significant efficacy in treating active psoriatic arthritis (PsA) in a Phase 3b study, achieving its primary endpoint of ACR20 and a major secondary endpoint related to structural damage progression at 24 weeks [1][2] - The drug is the first fully-human, dual-acting monoclonal antibody approved for PsA, targeting IL-23 and binding to CD64, which is crucial in the pathogenesis of immune-mediated diseases [1][4] - The APEX study will continue to assess the long-term efficacy of TREMFYA® over three years, with results expected to be presented at medical congresses [1][2] Company Overview - Johnson & Johnson maintains exclusive worldwide marketing rights for TREMFYA®, which is approved in multiple regions including the U.S., Europe, Canada, and Japan for treating moderate-to-severe plaque psoriasis and active PsA [5] - The company emphasizes the importance of early treatment to prevent irreversible joint damage in PsA patients, highlighting TREMFYA®'s unique ability to inhibit structural damage [1][3] Industry Context - Psoriatic arthritis is a chronic, inflammatory disease that can lead to significant joint damage and comorbidities, affecting patients typically between the ages of 30 and 50 [3][4] - The prevalence of PsA among individuals with plaque psoriasis is notable, with studies indicating that up to 30% may develop the condition [4]

Core Insights - TREMFYA® (guselkumab) has received FDA approval for the treatment of adults with moderately to severely active Crohn's disease, marking it as the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options [2][3] - The approval builds on previous indications for TREMFYA® in moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, highlighting Johnson & Johnson's commitment to addressing chronic immune-mediated diseases [3][8] - Clinical trials, including the GRAVITI and GALAXI studies, demonstrated TREMFYA®'s superiority over STELARA® in achieving clinical remission and endoscopic response, with significant efficacy results [2][6][7] Company Overview - Johnson & Johnson is a leader in healthcare innovation, focusing on developing treatments for chronic immune-mediated diseases, including inflammatory bowel disease [2][39] - The company maintains exclusive worldwide marketing rights to TREMFYA® and is committed to supporting patient access through programs like TREMFYA® withMe [2][10] Industry Context - Crohn's disease affects approximately three million Americans, and there is a significant need for effective treatment options as many patients continue to experience debilitating symptoms despite existing therapies [2][8] - The approval of TREMFYA® represents a significant advancement in the treatment landscape for Crohn's disease, providing a new option that allows for self-administration and flexibility in treatment regimens [2][3][6]