FDA approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease, expanding its use to the second major type of inflammatory bowel disease

Core Insights - Eli Lilly and Company announced the FDA approval of Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults, following its earlier approval for ulcerative colitis in October 2023 [1][5][10] - Omvoh targets interleukin-23p19 (IL-23p19) to reduce gastrointestinal inflammation and is the first biologic treatment in over 15 years to present two-year Phase 3 efficacy data for Crohn's disease at the time of approval [1][10] Group 1: Clinical Trial Results - In the Phase 3 VIVID-1 trial, 53% of patients treated with Omvoh achieved clinical remission at one year compared to 36% on placebo (p<0.001) [4] - 46% of Omvoh patients had visible healing of the intestinal lining at one year versus 23% on placebo (p<0.001) [4] - Among patients who achieved clinical remission and endoscopic response at one year, nearly 90% maintained clinical remission with two years of continuous Omvoh treatment [1][3] Group 2: Ongoing Studies and Safety Profile - Omvoh is being evaluated in the ongoing VIVID-2 study, which assesses its efficacy and safety for up to three years in adults with Crohn's disease [3] - The overall safety profile of Omvoh in Crohn's disease patients is consistent with its profile in ulcerative colitis patients, with common adverse reactions including upper respiratory tract infections and injection site reactions [3][6] Group 3: Market and Accessibility - Lilly has submitted marketing applications for Omvoh in Crohn's disease globally, including in the European Union and Japan, and it is currently approved in 44 countries for ulcerative colitis [5][6] - As of January 1, Omvoh has gained first-line biologic coverage from two of the three largest pharmacy benefit managers, enhancing patient access [6][7]