On March 28, 2025, the FDA approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD), marking a major expansion of its therapeutic footprint beyond PsO and PsA. Approval was based on data from GALAXI-2 and GALAXI-3, in which guselkumab demonstrated significant clinical and endoscopic remission versus placebo and ustekinumab through 48 weeks. The FDA noted particularly strong maintenance responses, mucosal healing, and steroid-sparing effects. The label includes both IV and SC induction followed by SC maintenance. With this approval, Tremfya becomes the first IL-23p19 inhibitor approved for both ulcerative colitis and Crohn’s disease, positioning it to compete against Stelara and Skyrizi in IBD. Commercial launch was supported by new data showing strong patient-reported outcomes and treatment persistence in inflammatory bowel diseases.

Citation: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-tremfya-crohns-disease

Implication: This approval firmly establishes Tremfya as a foundational IL-23 therapy across both IBD types, pressuring Skyrizi and Stelara.