Pharmaceutical company Eli Lilly and Company (NYSE:LLY) on Friday announced new data from the VIVID-2 open-label extension study demonstrating that most patients with moderately to severely active Crohn's disease receiving Omvoh (mirikizumab-mrkz) maintained long-term clinical remission and endoscopic response over two years.
Among patients in clinical remission at one year, 92.9% sustained remission at two years, while 87.6% maintained an endoscopic response.
Omvoh is the first IL-23p19 antagonist to demonstrate sustained multi-year efficacy and safety for Crohn's disease and ulcerative colitis. The study included patients with prior biologic failure, with 43.8% of participants having previously not responded to biologic therapies.
The safety profile of Omvoh in VIVID-2 was consistent with prior studies, with 6.8% of patients reporting a serious adverse event in the second year and 0.8% discontinuing treatment due to adverse events. Additional trials are ongoing to assess long-term efficacy and safety in paediatric and adult patients.
Omvoh received US Food and Drug Administration (FDA) approval for Crohn's disease in January 2025, and a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2024. Lilly has submitted global marketing applications, including in Canada, Japan and China.
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