Eli Lilly’s Omvoh for Crohn’s disease approved by FDA

Eli Lilly (LLY) announced that the FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh is now approved in the U.S. for two types of inflammatory bowel disease, following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis in adults. Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn’s disease at the time of approval. This approval is based on positive results from the Phase 3 VIVID-1 study of Omvoh in adults with moderately to severely active Crohn’s disease. Omvoh is also being studied in VIVID-2, an ongoing study evaluating the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn’s disease.