FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis
WEDNESDAY, Sept. 24, 2025 -- The U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.
With this approval, Tremfya is the first and only interleukin-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of ulcerative colitis and Crohn disease.
The approval is based on results from the phase 3 ASTRO trial, which evaluated the efficacy and safety of Tremfya SC induction therapy in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy and advanced therapies. In as little time as two weeks, early symptomatic response was observed with Tremfya compared with placebo and was sustained through week 24. Compared with placebo, significantly greater proportions of patients treated with Tremfya (400 mg SC every four weeks) achieved clinical remission (26 versus 7 percent) and endoscopic improvement (36 versus 12 percent) at week 12. These results were consistent with the FDA-approved 200 mg IV induction regimen.
"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," David T. Rubin, M.D., a study investigator from the University of Chicago, said in a statement. "With today's approval, ulcerative colitis 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 of the subcutaneous regimen of Tremfya was granted to Johnson & Johnson.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
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