FDA Approves Both SC and IV Guselkumab for Crohn's Disease Among Adult Patients
The U.S. Food and Drug Administration (FDA) on March 20 approved guselkumab as the first and only interleukin (IL)-23 inhibitor with both subcutaneous (SC) and intravenous (IV) induction options to treat moderately to severely active Crohn’s disease (CD) in adults.
Guselkumab was approved last year for treating moderate to severe ulcerative colitis. Findings from the phase III GRAVITI trial and the GALAXI program supported the approval in Crohn's; these trials collectively included more than 1,300 patients who had not responded to or could not tolerate conventional therapies or biologics.
Subcutaneous and IV guselkumab achieved significantly higher rates in inducing clinical remission (47% SC-56% IV vs 15-22% with placebo, P<0.001) and endoscopic response (34-36% vs 9-13%, P<0.001) at week 12.
Guselkumab also achieved significantly better week-48 outcomes compared with placebo, in clinical remission (59-65% vs 17%, respectively); endoscopic response (39-48% vs 5%); endoscopic remission (31-40% vs 6%) and deep remission (26-34% vs 4%.)
Pooled head-to-head data from the GALAXI studies showed superior responses on endoscopic endpoints with guselkumab versus the IL-12/23 blocker ustekinumab.
For more on these trials, see these summaries from trial investigators Dr Remo Panaccione, https://www.hmpgloballearningnetwork.com/site/aibdnet/videos/remo-panaccione-md-graviti-trials-guselkumab-crohns-disease and Dr David Rubin https://www.hmpgloballearningnetwork.com/site/aibdnet/david-rubin-md-galaxi-2-and-3-trials-guselkumab-crohns-disease.
Reference:
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. News release. Johnson & Johnson; March 20, 2025. Accessed March 24. 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
