J&J's TREMFYA wins FDA approval for subcutaneous ulcerative colitis treatment

Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration approved a subcutaneous induction regimen of TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis.

The approval makes TREMFYA the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options for ulcerative colitis and Crohn's disease treatment. The drug can now be self-administered from the start of treatment through subcutaneous injection.

The approval was based on results from the Phase 3 ASTRO trial. In the study, significantly greater proportions of patients treated with TREMFYA 400 mg subcutaneously every four weeks achieved clinical remission (26% versus 7%) and endoscopic improvement (36% versus 12%) at Week 12 compared to placebo patients.

The subcutaneous induction results were consistent with the previously approved 200mg intravenous induction regimen, which achieved clinical remission rates of 23% versus 8% for placebo and endoscopic improvement rates of 27% versus 11% for placebo.

The recommended subcutaneous induction dosage is 400 mg administered at Weeks 0, 4 and 8, given as two consecutive injections of 200 mg each. Maintenance dosage options include either 100 mg every 8 weeks or 200 mg every 4 weeks by subcutaneous injection.

Johnson & Johnson previously received FDA approval for TREMFYA with intravenous induction for ulcerative colitis in September 2024, and approval for both subcutaneous and intravenous induction options for Crohn's disease in March 2025.

The company announced it is initiating a head-to-head study comparing TREMFYA versus Skyrizi (risankizumab) in Crohn's disease treatment.

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