Guselkumab (Tremfya) Gains FDA Approval for Crohn Disease: Daily Dose

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On March 21, 2025, we reported on the US FDA approval of guselkumab (Tremfya; Johnson & Johnson) for the treatment of adults with moderately to severely active Crohn disease (CD).

The approval

The approval is based on the FDA's review of data from multiple phase 3 clinical trials that included results of the GALAXI program. In this head-to-head study guselkumab proved superior to ustekinumab (Stelara; Janssen) across pooled endoscopic endpoints, making guselkumab the "only IL-23 inhibitor to achieve this in a double-blinded registrational program," according to the Johnson & Johnson March 20 announcement. With this approval, guselkumab also becomes the only IL-23 inhibitor with induction options for both subcutaneous (SC) and intravenous (IV) administration.

A long-term extension of the GALAXI studies will assess clinical, endoscopic, and safety outcomes of guselkumab treatment of CD over 5 years.

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