HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved a subcutaneous induction regimen of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA is now the first and only IL-23 inhibitor to offer both subcutaneous and intravenous induction options for the treatment of ulcerative colitis and Crohn’s disease, which together affect about three million Americans.
TREMFYA is the first approved fully human, 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 drives immune-mediated diseases including ulcerative colitis.
“Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians,” said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine and study investigator. “With today’s approval, UC patients and providers now have the choice of starting TREMFYA with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice.”
The approval is based on results from the Phase 3 ASTRO trial, which evaluated the efficacy and safety of TREMFYA subcutaneous induction therapy in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional or advanced therapies. Patients treated with TREMFYA 400 mg subcutaneous every four weeks achieved clinical remission rates of 26 percent compared with 7 percent for placebo, and endoscopic improvement rates of 36 percent compared with 12 percent for placebo at Week 12.
Results were consistent with the 200 mg intravenous induction regimen approved in 2024, which showed remission rates of 23 percent compared with 8 percent for placebo, and endoscopic improvement of 27 percent compared with 11 percent for placebo.
“With today’s approval, TREMFYA is the first and only IL-23 inhibitor to offer inflammatory bowel disease patients robust clinical and endoscopic results with a fully subcutaneous regimen, now across both ulcerative colitis and Crohn’s disease,” said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “The initiation of a head-to-head study in Crohn’s disease is a further testament to our commitment to advancing the clinical evidence of TREMFYA in IBD.”
The recommended subcutaneous induction dosage is 400 mg at Weeks 0, 4, and 8. Maintenance therapy can be continued at either 100 mg every 8 weeks or 200 mg every 4 weeks.
Johnson & Johnson is also initiating a head-to-head study to compare TREMFYA with Skyrizi (risankizumab) in Crohn’s disease.
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