HORSHAM, Pa., Sept. 19, 2025 — Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for subcutaneous (SC) induction in adults with moderately to severely active ulcerative colitis (UC). With this approval, TREMFYA® becomes the first and only IL-23 inhibitor offering a fully subcutaneous regimen, complementing its intravenous (IV) induction options in UC and Crohn’s disease (CD), conditions collectively affecting nearly three million Americans.
Science Significance
TREMFYA® is a fully-human, dual-acting monoclonal antibody that neutralizes IL-23 while binding CD64 on cells producing IL-23, targeting the root of immune-mediated inflammation. IL-23 is a cytokine secreted by activated monocytes, macrophages, and dendritic cells that drives UC pathogenesis. The Phase 3 ASTRO trial demonstrated significant clinical remission and endoscopic improvement at Week 12, with 26% of patients achieving remission and 36% showing endoscopic improvement versus 7% and 12% for placebo, respectively. Results were comparable to IV induction, with benefits observed as early as two weeks and sustained through Week 24, validating SC induction as a potent, rapid, and durable therapy.
Regulatory Significance
This FDA approval builds on prior approvals of TREMFYA® IV induction for UC (2024) and SC/IV induction for CD (2025). The ASTRO trial, a treat-through, Phase 3 study, confirmed efficacy and safety in patients with inadequate responses to conventional therapies, biologics, or JAK inhibitors. SC induction now provides patients and clinicians the ability to start TREMFYA® at home, reducing logistical challenges associated with IV infusions. This milestone reinforces regulatory confidence in TREMFYA®’s dual administration routes and strengthens its positioning among approved selective IL-23 inhibitors.
Business Significance
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The SC induction approval enhances Johnson & Johnson’s leadership in inflammatory bowel disease (IBD) therapeutics. TREMFYA® offers a flexible, patient-friendly dosing option that could drive market uptake, particularly among patients seeking at-home care. J&J is also initiating a head-to-head trial against Skyrizi® (risankizumab) in Crohn’s disease, aiming to demonstrate TREMFYA®’s superiority and solidify its competitive edge. Additionally, the TREMFYA withMe program enables commercially insured adults to receive their first induction dose within 24 hours, improving access and adherence while supporting commercial growth.
Patients’ Significance
Historically, initiation of IL-23 inhibitors required IV infusions, creating barriers for patients. SC induction enables self-administration, empowering patients to manage treatment from home. ASTRO data confirmed efficacy across subgroups, including those with severe or refractory disease. Maintenance regimens following SC induction—100 mg every eight weeks or 200 mg every four weeks—showed clinically meaningful improvements in remission and endoscopic scores at Week 24, supporting sustained disease control and enhancing quality of life.
Policy Significance
This approval aligns with policy trends emphasizing patient-centric care, home-based treatment, and reduced reliance on infusion centers. By expanding access to self-administered biologics, TREMFYA® contributes to value-based care initiatives and reduces pressure on healthcare infrastructure. Regulatory validation of both SC and IV options support broader adoption of flexible, evidence-based therapies for chronic immune-mediated diseases, including UC and CD.
Transaction Highlights
TREMFYA® subcutaneous induction is administered as 400 mg at Weeks 0, 4, and 8, delivered as two consecutive 200 mg injections per dose. Following induction, patients continue maintenance therapy with either 100 mg every 8 weeks or 200 mg every 4 weeks, depending on their clinical needs. The intravenous induction option remains available at 200 mg administered at Weeks 0, 4, and 8, providing flexibility for clinicians and patients. Globally, TREMFYA® is approved for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease, with Johnson & Johnson maintaining exclusive worldwide marketing rights through Janssen Biotech, Inc. This milestone strengthens Johnson & Johnson’s portfolio in immunology and gastroenterology and is supported by pivotal clinical programs including ASTRO, QUASAR, GRAVITI, and GALAXI, highlighting the company’s commitment to innovative therapies and broad patient access.
Source: Johnson & Johnson Press Release
