FDA Approves Johnson & Johnson's Tremfya For Crohn's Disease

Core Insights - The FDA has approved Johnson & Johnson's Tremfya (guselkumab) as the first IL-23 inhibitor for adults with moderately to severely active Crohn's disease, offering both subcutaneous and intravenous induction options [1] - The approval is based on results from multiple Phase 3 trials involving over 1,300 patients who were either intolerant to or had failed conventional therapies [2] - Tremfya has now received its fourth indication in the U.S., following approvals for plaque psoriasis, psoriatic arthritis, and ulcerative colitis [4] Sales Performance - In 2024, Tremfya generated sales of $3.67 billion, reflecting a 17% year-over-year increase [5] Clinical Studies - The GRAVITI study demonstrated the efficacy of Tremfya SC induction and maintenance therapy compared to placebo [3] - Data from the GALAXI clinical program indicated that Tremfya outperformed Johnson & Johnson's Stelara in all pooled endoscopic endpoints [3]