Eli Lilly and Company (Lilly) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh (mirikizumab).
This treatment is intended for adults with moderately to severely active Crohn’s disease who have not responded to, lost response to, or were intolerant to conventional or biologic therapies.
Omvoh is an interleukin-23p19 (IL-23p19) antagonist. It was previously approved in the European Union, US, and Japan in 2023 for the treatment of adults with moderately to severely active ulcerative colitis (UC).
This new positive opinion brings Omvoh closer to securing European regulatory approval for the treatment of moderately to severely active Crohn’s disease.
The European Commission is expected to issue its final decision within the next one to two months.
Lilly immunology development senior vice president Mark Genovese said: “Disruptive symptoms of Crohn’s disease, such as bowel urgency, can interfere with all aspects of life, leaving many people searching for treatments that can help them fully participate in the things that they enjoy.
“Given the efficacy we saw on clinical remission and endoscopic response, combined with the improvements in bowel urgency and histological inflammation, this positive CHMP opinion for Omvoh brings us a step closer to advancing care for more people with inflammatory bowel disease around the world.”
The positive CHMP opinion for mirikizumab is supported by data from the Phase 3 VIVID-1 study, which evaluated its safety and efficacy in adults with moderately to severely active Crohn’s disease.
In VIVID-1, mirikizumab demonstrated statistically significant improvements compared to placebo in both co-primary endpoints, which are composite endoscopic response and composite clinical remission, at week 12 and week 52.
It also outperformed placebo in all major secondary endpoints, including composite steroid-free clinical remission and endoscopic outcomes.
Additionally, patients treated with mirikizumab showed improvements in bowel urgency, as measured on a patient-centric 11-point scale developed by Lilly.
Mirikizumab’s safety profile in Crohn’s disease was consistent with its established safety record in UC patients.
Lilly has submitted marketing applications for Omvoh for the treatment of Crohn’s disease in multiple regions, including the US and Japan.
Regulatory decisions are expected from these authorities beginning in the first half of 2025. In July this year, Lilly unveiled its plans to acquire Morphic for $3.2bn, in a move to expand its inflammatory bowel disease (IBD) drugs portfolio.
