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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