Eli Lilly and Company's Omvoh (mirikizumab) has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of adults with moderately to severely active Crohn's disease. This recommendation marks a significant step toward expanding the availability of Omvoh, an interleukin-23p19 (IL-23p19) antagonist, for patients who have not responded adequately to conventional or biologic therapies. The European Commission is expected to make a final decision on approval within the next one to two months.
The CHMP's positive opinion was primarily based on data from the Phase 3 VIVID-1 trial. This randomized, double-blind study evaluated the safety and efficacy of mirikizumab compared to placebo and ustekinumab in adult patients with moderately to severely active Crohn's disease. The trial included patients with and without prior biologic failure.
VIVID-1 Trial Results
The VIVID-1 trial demonstrated that patients treated with mirikizumab achieved statistically significant improvements compared to those treated with placebo regarding the co-primary endpoints: composite endoscopic response and composite clinical remission, at both Week 12 and Week 52. Additionally, mirikizumab demonstrated statistically significant improvements in all major secondary endpoints, including composite steroid-free clinical remission and endoscopic outcomes.
Notably, VIVID-1 was the first pivotal Crohn's disease trial to report benefits in bowel urgency, a particularly challenging symptom for patients. This was measured using a patient-centric, 11-point scale developed by Lilly. Furthermore, the trial showcased improvements in histologic outcomes, aligning with the European Crohn's and Colitis (ECCO) position statement on mucosal histopathology. Stefan Schreiber, M.D., Ph.D., director of the Clinic for Internal Medicine I at Kiel Campus of the University Hospital Schleswig-Holstein, emphasized the potential for Omvoh to provide comprehensive disease control, including relief from disruptive symptoms and control of intestinal inflammation.
Safety and Tolerability
The safety profile of mirikizumab in Crohn's disease patients was consistent with its established safety profile in ulcerative colitis (UC), for which Omvoh is already approved in the European Union, U.S., Japan, and 44 other countries. This consistency supports the potential for Omvoh to be a well-tolerated treatment option for a broader range of inflammatory bowel disease (IBD) patients.
Regulatory Landscape and Future Expectations
Lilly has also submitted marketing applications for Omvoh in Crohn's disease in the U.S. and Japan, with regulatory decisions anticipated in the first half of 2025. If approved by the European Commission, Omvoh will be the first treatment for Crohn's disease to include results demonstrating improvements of histologic measures of inflammation included in its label.
Mark Genovese, M.D., senior vice president of Lilly Immunology development, noted that the positive CHMP opinion brings them closer to advancing care for more people with inflammatory bowel disease around the world, given the efficacy seen on clinical remission and endoscopic response, combined with the improvements in bowel urgency and histological inflammation.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive bowel damage, disability, and reduced quality of life. Current treatments do not provide remission for the majority of patients or maintain it long term. Omvoh's approval would represent a significant advancement in the treatment options available for this patient population.
