FDA Approves Lilly’s Omvoh for Crohn’s Disease, Expanding Treatment Options

FDA Approval:
The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults145.

Clinical Efficacy:
The approval is based on the Phase 3 VIVID-1 trial, which showed significant improvements in clinical remission and endoscopic response rates compared to placebo after one year. 53% of patients treated with Omvoh achieved clinical remission, and 46% had visible healing of the intestinal lining at one year145.

Long-term Remission:
Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in an open-label extension15.

Mechanism of Action:
Omvoh works by targeting interleukin-23p19 (IL-23p19), a key contributor to intestinal inflammation, making it a novel treatment option for Crohn's disease15.

Global Submissions:
Lilly has also submitted marketing applications for Omvoh in Crohn's disease in the European Union and Japan, with additional global regulatory submissions planned15.

Patient Support:
Lilly is committed to serving patients living with Crohn's disease and is working with insurers, health systems, and providers to enable access to Omvoh, including offering co-pay assistance for eligible, commercially insured patients15.

Sources:

1. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease

4. https://www.pharmexec.com/view/fda-approves-eli-lilly-omvoh-crohn-disease

5. https://www.prnewswire.com/news-releases/fda-approves-lillys-omvoh-mirikizumab-mrkz-for-crohns-disease-expanding-its-use-to-the-second-major-type-of-inflammatory-bowel-disease-302352349.html