Eli Lilly and Company — Omvoh FDA Review (BLA761279, ORIG 1, 2023)
Eli Lilly and Company · 2023 · FDA Review (openFDA) · company profile →
Report summary
Eli Lilly's Omvoh (mirikizumab-mrkz) for moderately to severely active ulcerative colitis (UC) was recommended for approval after resolving manufacturing facility deficiencies that initially led to a Complete Response. Clinical trials (AMAN and AMBG) demonstrated mirikizumab's superiority over placebo in achieving clinical remission during both induction and maintenance phases, with a favorable safety profile and no new safety signals. The FDA review encompassed extensive nonclinical and clinical pharmacology, toxicology, and efficacy/safety data, including detailed analyses of exposure-response, adverse events, and specific safety concerns. While some discrepancies existed regarding the clinical meaningfulness of urgency scores, the overall data supported the drug's efficacy and safety, leading to postmarketing requirements for further studies.
Key findings — cited to the page
| IC50 for inhibition of IL-17 production (human IL-23) | 82 pM | LY3074828 · p.379 |
| IC50 for inhibition of IL-17 production (cynomolgus monkey IL-23) | 120 pM | LY3074828 · p.379 |
| Priority or Standard | Standard resubmission | Omvoh (mirikizumab) · p.2 |
| Received Date | May 24, 2023 | Omvoh (mirikizumab) · p.2 |
| PDUFA Goal Date | November 24, 2023 | Omvoh (mirikizumab) · p.2 |
| Review Completion Date | October 26, 2023 | Omvoh (mirikizumab) · p.2 |
| Proposed Indication | Adult patients with moderately to severely active ulcerative colitis (UC) | Omvoh (mirikizumab) · p.2 |
| Recommended Regulatory Action | Approval | Omvoh (mirikizumab) · p.2 |
| Induction dosage regimen | 300 mg intravenous (IV) for at least 30 minutes at Week 0, Week 4, and Week 8 | Omvoh (mirikizumab) · p.2 |
| Maintenance dosage regimen | 200 mg subcutaneous (SC) every 4 weeks after completion of induction dosing | Omvoh (mirikizumab) · p.2 |
| Original BLA submission date | March 30, 2022 | Omvoh (mirikizumab) · p.4 |
| Submit Date | May 24, 2023 | Omvoh (mirikizumab) · p.2 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →