Eli Lilly's Omvoh® Gains FDA Approval for Crohn's Disease Treatment
Thursday, January 16, 2025
Eli Lilly and Company has secured approval from the United States Food and Drug Administration (FDA) for Omvoh® (mirikizumab-mrkz) as a treatment for moderately to severely active Crohn's disease in adults.
Omvoh is a biologic treatment targeting the IL-23 pathway, addressing the underlying inflammation in moderate to severe ulcerative colitis and Crohn's disease, providing new hope for patients with these chronic conditions.
This milestone expands Omvoh's reach to a second major inflammatory bowel disease (IBD), complementing its earlier approval in October 2023 for ulcerative colitis.
Omvoh, which targets interleukin-23p19 (IL-23p19), a key protein in intestinal inflammation, is designed to reduce gastrointestinal inflammation.
It is the first biologic therapy in over 15 years to include two-year efficacy data for Crohn's disease at the time of approval.
The FDA’s decision is supported by results from the Phase 3 VIVID-1 study, which showed Omvoh's effectiveness in patients with Crohn's disease who had not responded to previous treatments.
The study demonstrated that over 50% of patients receiving Omvoh achieved clinical remission, and nearly 46% showed healing of the intestinal lining after one year of treatment.
Long-term data from the ongoing VIVID-2 extension study indicates sustained clinical benefits for patients continuing treatment for up to two years.
The safety profile observed in Crohn's disease aligns with Omvoh’s established use in ulcerative colitis, with common adverse effects including upper respiratory infections, injection site reactions, headaches, and elevated liver enzymes.
Eli Lilly is advancing regulatory submissions for Omvoh in additional markets, including the European Union and Japan, while ensuring patient access in the US through insurance coverage and support programmes.
Source: lilly.com
