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

Core Insights - TREMFYA® (guselkumab) has received FDA approval for the treatment of adults with moderately to severely active Crohn's disease, marking it as the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options [2][3] - The approval builds on previous indications for TREMFYA® in moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, highlighting Johnson & Johnson's commitment to addressing chronic immune-mediated diseases [3][8] - Clinical trials, including the GRAVITI and GALAXI studies, demonstrated TREMFYA®'s superiority over STELARA® in achieving clinical remission and endoscopic response, with significant efficacy results [2][6][7] Company Overview - Johnson & Johnson is a leader in healthcare innovation, focusing on developing treatments for chronic immune-mediated diseases, including inflammatory bowel disease [2][39] - The company maintains exclusive worldwide marketing rights to TREMFYA® and is committed to supporting patient access through programs like TREMFYA® withMe [2][10] Industry Context - Crohn's disease affects approximately three million Americans, and there is a significant need for effective treatment options as many patients continue to experience debilitating symptoms despite existing therapies [2][8] - The approval of TREMFYA® represents a significant advancement in the treatment landscape for Crohn's disease, providing a new option that allows for self-administration and flexibility in treatment regimens [2][3][6]