FDA Approves Guselkumab for Adult Patients With Crohn Disease

The FDA has approved guselkumab (Tremfya) as the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for adults with moderate to severe active Crohn disease. | Image Credit: Nirusmee - stock.adobe.com

The FDA approved guselkumab (Tremfya; Johnson & Johnson) for adult patients with moderate to severe active Crohn disease.1 The approval marks the first and only IL-23 inhibitor that offers both subcutaneous and intravenous induction options.

“Tremfya provides people living with Crohn’s disease and their healthcare providers a new treatment option that is supported by data from multiple phase 3 studies, including pooled analyses showing statistical superiority versus Stelara across four endoscopic or combined clinical and endoscopic endpoints,” Chris Gasink, MD, vice president of medical affairs at Johnson & Johnson Innovative Medicine, said in a statement.

The phase 3 GRAVITI study (NCT05197049) found the efficacy and safety of guselkumab in adult patients via an analysis of guselkumab subcutaneous induction and maintenance therapy vs placebo. The results demonstrated the superiority of guselkumab over ustekinumab (Stelara) in all pooled endoscopic endpoints, making it the only IL-23 inhibitor to achieve this in a double-blinded registrational program.

The FDA has now approved guselkumab across 4 indications in the US; it is also approved for moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis (UC). In September 2024, the FDA granted the latter approval, supported by the QUASAR study, which evaluated the efficacy and safety of guselkumab in patients who had an inadequate response or intolerance to conventional therapy, other biologics, or Janus kinase inhibitors.2

References

1. 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; 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

2. Tremfya (guselkumab) receives US FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. News release. Johnson & Johnson; September 11, 2024. Accessed March 21, 2025. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease