Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn's Disease (CD)
Shots:
- Approval was based on a P-III (VIVID-1) trial assessing Omvoh vs PBO in mod. to sev. CD patients, unresponsive/intolerable to corticosteroids, BRMs &/or biologics, post its approval for UC in Dec 2023. Regulatory submissions are filed globally, incl. Japan & the EU, with other submissions underway
- Study showed 53% vs 36% clinical remission & 46% vs 23% improved endoscopic response at 1yr., with early improvement (32% vs 11%) at 3mos. Non-responders switched to Omvoh at 12wks.
- The VIVID-2 (OLE) study is evaluating Omvoh for ~3yrs., where ~80% patients sustained improved endoscopic response & ~90% maintained clinical remission after an extra 1yr. of therapy
Ref: Eli Lilly | Image: Eli Lilly
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
