Johnson & Johnson's TREMFYA Gains FDA Nod For SC Induction In Ulcerative Colitis

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(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). With this approval, TREMFYA becomes the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn's disease (CD).

The company said it is committed to supporting access to all its treatments, including offering a patient support program called TREMFYA withMe. Commercially insured adult patients who are prescribed TREMFYA for UC may be eligible to receive their first induction treatment in as little as 24 hours through TREMFYA withMe.

In September 2024, Johnson & Johnson received FDA approval of TREMFYA (with IV induction) for the treatment of adults with moderately to severely active UC, based on the Phase 3 QUASAR study.

In March 2025, TREMFYA received FDA approval, including both SC and IV induction options, for the treatment of adults with moderately to severely active CD. Johnson & Johnson is initiating the first IL-23 inhibitor head-to-head study seeking to demonstrate the superiority of TREMFYA vs. Skyrizi (risankizumab), representing an important next step in Crohn's disease research.

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