Eli Lilly and Company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Omvoh® (mirikizumab) for approval. Omvoh, an interleukin-23p19 (IL-23p19) antagonist, is proposed for the treatment of adults with moderately to severely active Crohn’s disease who have experienced an inadequate response, lost response, or intolerance to either conventional or biologic therapies.
Dr. Stefan Schreiber, director of the Clinic for Internal Medicine I at the University Hospital Schleswig-Holstein in Kiel, Germany, highlighted the significance of this development, stating:
“Omvoh represents a promising treatment option for patients with Crohn’s disease, a condition where most current therapies fail to achieve or sustain remission long-term. This therapy could offer comprehensive disease control, including symptom relief from bowel urgency and visible intestinal healing as defined by endoscopic and histologic measures.”
A Step Toward Expanded Approval
Omvoh was previously approved in 2023 as a first-in-class therapy for moderately to severely active ulcerative colitis (UC) in the EU, U.S., and Japan. It is now approved in 44 countries worldwide. The positive CHMP opinion paves the way for regulatory approval in the EU for Crohn’s disease, with the final decision from the European Commission expected within one to two months.
Evidence Supporting the Recommendation
The recommendation is based on results from the Phase 3 VIVID-1 study, which evaluated the safety and efficacy of mirikizumab in adults with moderately to severely active Crohn’s disease. The study compared mirikizumab with both a placebo and an active control, ustekinumab. Key findings included:
- Statistically significant improvements in the co-primary endpoints: composite endoscopic response and clinical remission compared to placebo.
- Achievement of all major secondary endpoints, including steroid-free clinical remission and endoscopic outcomes at both 12 and 52 weeks.
- Reductions in bowel urgency severity, assessed through a patient-centric scale developed by Lilly.
Notably, the VIVID-1 trial became the first pivotal Crohn’s disease study to align with the European Crohn’s and Colitis Organisation’s (ECCO) guidelines on histologic healing. Histologic healing, a strict measure of inflammation reduction, is associated with better long-term outcomes for Crohn’s patients.
Mirikizumab demonstrated a safety profile in Crohn’s disease consistent with its known profile in UC, with no unexpected adverse events. Results from VIVID-1 were recently published in The Lancet.
Sustained Efficacy and Broader Impact
Beyond the VIVID-1 findings, multi-year data presented at the American College of Gastroenterology (ACG) Annual Meeting in October demonstrated sustained efficacy and safety for both UC and Crohn’s disease.
Dr. Mark Genovese, senior vice president of Lilly Immunology Development, emphasized the therapy’s potential:
“Crohn’s disease disrupts lives with symptoms like bowel urgency, which impact day-to-day activities. Omvoh’s demonstrated efficacy in clinical remission, endoscopic response, and histological healing brings us closer to providing meaningful care for those with inflammatory bowel diseases globally.”
Next Steps for Omvoh
In addition to the EU, Lilly has submitted regulatory applications for mirikizumab in Crohn’s disease to authorities in the U.S., Japan, and other regions. Decisions from these regulatory bodies are expected to begin in the first half of 2025.
