TREMFYA® Receives FDA Approval for Crohn's Disease

TREMFYA® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen.

Supported by data from the GALAXI study, TREMFYA® is the only IL-23i to show superiority versus STELARA® in all pooled endoscopic endpoints within a double-blinded registrational trial.

TREMFYA® approval in Crohn's disease builds upon recent ulcerative colitis FDA approval, marking the fourth indication for this dual-acting IL-23i in the U.S.

HORSHAM, Pa., March 20, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has 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's disease (CD), a chronic inflammatory condition of the gastrointestinal tract.

This milestone builds upon the FDA approval of TREMFYA® in moderately to severely active ulcerative colitis (UC), one of two main forms of inflammatory bowel disease (IBD), which impacts the lives of nearly three million Americans. TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including CD.

“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. “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.”

This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics. The GRAVITI study evaluated TREMFYA® SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed TREMFYA® was superior to STELARA® in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The comprehensive results from these Phase 3 studies demonstrated the robust efficacy of SC or IV TREMFYA® in achieving clinical and endoscopic endpoints.

Highlights from the Pivotal Studies:

Week 12 Results:

Week 48 Results:

TREMFYA® 100 mg SC maintenance q8w starting at Week 16 vs. placebo:

• Clinical remission: 59% vs. 17%
• Endoscopic response: 39% vs. 5%
• Endoscopic remission: 31% vs. 6%

TREMFYA® 200 mg SC maintenance q4w starting at Week 12 vs. placebo:

• Clinical remission: 65% vs. 17%
• Endoscopic response: 48% vs. 5%
• Endoscopic remission: 40% vs. 6%

TREMFYA® provides people living with Crohn's disease and their healthcare providers with a new treatment option that is supported by data from multiple Phase 3 studies.

Safety Information

What is the most important information I should know about TREMFYA®?

TREMFYA® may cause serious side effects, including symptoms of serious allergic reactions. Tell your healthcare provider right away if you have an infection or symptoms of an infection.

About TREMFYA®

TREMFYA® is a prescription medicine approved in the U.S. to treat moderately to severely active Crohn's disease and is also approved for other conditions.