Most patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease achieved sustained clinical remission and endoscopic response at two years

Core Insights - Eli Lilly's Omvoh (mirikizumab) demonstrates long-term efficacy and safety for treating moderately to severely active Crohn's disease and ulcerative colitis, with over 90% of patients maintaining clinical remission after two years of continuous treatment [1][3][6] Clinical Outcomes - More than 90% of patients who were in clinical remission at one year sustained it with two years of continuous treatment [1] - Nearly 90% of patients who achieved endoscopic response at one year maintained it at two years [1] - Among patients treated in VIVID-2, 87.6% maintained endoscopic response, defined by a ≥50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score [4] - Among patients who were in endoscopic remission at one year, 78.6% maintained endoscopic remission at two years [4] - 60.8% of patients not in clinical remission at one year gained clinical remission during the second year of treatment [4] - 35.4% of patients not in endoscopic remission at one year gained endoscopic remission during the second year of treatment [4] Safety Profile - The long-term safety profile of Omvoh was consistent with known safety data, with 6.8% of patients reporting serious adverse events during the second year of treatment [3] - Only 0.8% of patients discontinued treatment due to adverse events [3] Regulatory Status - Omvoh was approved by the FDA for the treatment of moderately to severely active Crohn's disease in January 2025 [5] - The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for Omvoh in December 2024 [5] - Omvoh is also approved in 44 countries for treating moderately to severely active ulcerative colitis [5] Ongoing Research - Omvoh is the first IL-23p19 antagonist to show long-term, sustained efficacy and safety for both Crohn's disease and ulcerative colitis [6] - Ongoing trials are evaluating the long-term efficacy and safety of Omvoh in pediatric patients and adults, as well as a Phase 4 real-world evidence study [6] Clinical Trial Program - The VIVID-1 study was a Phase 3 randomized, double-blind, placebo-controlled study that established the efficacy of Omvoh [7] - Participants who completed VIVID-1 were eligible for VIVID-2, which focused on the long-term effects of Omvoh [7] - A modified non-responder imputation method indicated that 81.8% of endoscopic responders at year one maintained endoscopic response at two years [7]