The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended the potential approval of Omvoh (mirikizumab) by US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). This treatment is intended for adults with moderately to severely active Crohn’s disease who have not responded adequately to conventional therapy or biologic treatments, or who have experienced intolerance to these options.
Mirikizumab: A Novel Treatment for Crohn’s Disease
Mirikizumab, classified as an interleukin-23p19 (IL-23p19) antagonist, has already received approval in the European Union (EU), the US, and Japan for the treatment of moderate to severe active ulcerative colitis, making it the world’s first drug of its kind for this indication. In October of this year, a market filing for mirikizumab was submitted in China, seeking approval for its use in moderate to severe Crohn’s disease.
CHMP’s Decision Based on Phase III VIVID-1 Study
The CHMP’s support for mirikizumab is grounded in the outcomes of the Phase III VIVID-1 study, which evaluated the efficacy and safety of mirikizumab in comparison with a placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn’s disease (CD). The study demonstrated that mirikizumab achieved statistically significant improvements over placebo at both Week 12 and Week 52 on the co-primary endpoints of composite endoscopic response and composite clinical remission. Additionally, mirikizumab showed positive results across all major secondary endpoints, including composite steroid-free clinical remission and endoscopic outcomes.-Fineline Info & Tech
