FDA Approves Johnson & Johnson’s Tremfya for Crohn Disease

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The FDA has approved Johnson & Johnson’s (J&J) Tremfya (guselkumab) for the treatment of moderately to severely active Crohn disease (CD). The regulatory action makes Tremfya the first and only interleukin (IL)-23 inhibitor to offer both subcutaneous (SC) and intravenous (IV) induction options for CD. Approval was based on positive results from multiple trials, including the Phase III GRAVITI trial and Phase II/III GALAXI trial. Pooled analyses showed Tremfya’s statistical superiority over Stelara (ustekinumab) across certain clinical and endoscopic endpoints.¹

“Despite the progress in the management of CD, many patients experience debilitating symptoms and are in need of new treatment options,” GRAVITI lead investigator Remo Panaccione, MD, FRCPC, professor of medicine, director of the inflammatory bowel disease unit at the University of Calgary, said in a press release. “The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both (SC) and (IV) induction regimens. Importantly, the fully (SC) regimen offers choice and flexibility for patients and providers that have not been available before.”

The randomized, double-blind, placebo-controlled GRAVITI study evaluated SC induction of Tremfya in adults with moderately to severely active CD who experienced an inadequate response or failed to tolerate conventional or biologic therapy. Patients were randomly assigned to receive either 400 mg of SC Tremfya every four weeks (q4w) followed by 200 mg of SC Tremfya q4w, 400 mg of SC Tremfya q4w followed by 100 mg of SC Tremfya every eight weeks (q8w), or a placebo.

Results found that 56% of patients treated with Tremfya experienced improvement in symptoms compared to 22% in the placebo group, while 34% of patients experienced endoscopic response compared to 15% in the placebo group. At week 48, 59% of patients in the 100 mg q8w group and 65% in the 200 mg q4w group remained in remission compared to 17% in the placebo group. Additionally, 39% in the 100 mg q8w group and 48% in the 200 mg q4w group experienced endoscopic response, while 26% in the 100 mg q8w group and 34% in the 200 mg q4w group reached full remission, defined as both clinical and endoscopic remission.

The randomized, double-blind, placebo-controlled, active-controlled global, multicenter GALAXI program evaluated the efficacy and safety of Tremfya in patients with moderately to severely active CD who had an inadequate response or intolerance to conventional therapies. The GALAXI program included the Phase II, dose-ranging GALAXI 1 trial, and the independent, identically designed, confirmatory Phase III GALAXI 2 and GALAXI 3 trials. Patients were randomly assigned to receive either 200 mg of IV Tremfya q4w until week eight, followed by either 200 mg SC q4w or 100 mg SC q8w, a biologic active control, or placebo.

Results found that at 12 weeks, 47% of patients in both GALAXI trials demonstrated clinical remission compared to 15% in the placebo group. Additionally, 36% in GALAXI 2 and 34% in GALAXI 3 experienced an endoscopic response.

At 48 weeks, 59% in the 100 mg q8w group and 65% in the 200 mg q4w group stayed in remission compared to 17% in the placebo group. Further, 39% in the 100 mg q8w group and 48% in the 200 mg q4w group experienced endoscopic response, while 26% in the 100 mg q8w cohort and 34% in the 200 mg q4w cohort experienced deep remission, which includes both clinical and endoscopic remission.¹

“Tremfya is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active CD. With the approval of Tremfya, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” said Chris Gasink, MD, VP, medical affairs, gastroenterology & autoantibody, J&J Innovative Medicine, in the press release. “Tremfya provides people living with CD and their healthcare providers a new treatment option that is supported by data from multiple Phase III studies, including pooled analyses showing statistical superiority versus Stelara across four endoscopic or combined clinical and endoscopic endpoints.”

This marks the fourth approval for Tremfya, with previously approved indications including moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis (UC). J&J has also submitted a supplemental Biologics License Application to the FDA for the approval of an SC induction regimen of Tremfya for moderately to severely active UC.¹

Reference

1. 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. J&J. March 20, 2025. Accessed March 21, 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