FDA Approves Tremfya for the Treatment of Adults With Moderate to Severe Crohn Disease

On Friday, March 21, U.S. FDA approved Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn disease (CD), as noted in a Johnson & Johnson announcement.

This approval is backed by the findings of multiple phase III studies that analyzed 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy such as corticosteroids or biologics. Notably, data from the GALAXI clinical program showed Tremfaya was superior to Stelara across all endoscopic end points, making it the only IL-23 inhibitor to achieve this in a double-blinded registrational trial.

“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Remo Panaccione, MD, FRCPC, Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study, which assessed Tremfya against placebo. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”

Source:

Johnson&Johnson. 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 Crohn’s disease. JNJ. 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 Published Online March 20, 2025. Accessed Online March 24, 2025.