FDA

Tremfya approved for Crohn disease

March 26, 2025

FDA approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active Crohn disease (CD).

Efficacy

Approval of the new indication was based on data from three phase 3 trials involving >1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics: GALAXI 2 and GALAXI 3 (NCT03466411) and GRAVITI (NCT05197049). Results of these studies demonstrated robust efficacy of SC or IV Tremfya in achieving clinical and endoscopic endpoints, according to a manufacturer press release.

Safety

The most common adverse reactions reported with guselkumab in patients with CD were respiratory tract infections, abdominal pain, injection site reactions, headache, fatigue, arthralgia, diarrhea, and gastroenteritis.

Sources:

Johnson & Johnson. Tremfya (guselkumab) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s024lbl.pdf Revised March 2025. Accessed March 25, 2025.

US FDA approves Tremfya® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease. [News release]. Johnson & Johnson. 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-the-first-and-only-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease