Eli Lilly and Company — Omvoh EMA EPAR variation assessment report (EMEA/H/C/005122, 2023)
Eli Lilly and Company · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
Eli Lilly's Omvoh (mirikizumab) variation application for Crohn's disease (CD) was assessed by the EMA. The application sought to extend marketing authorization for moderately to severely active CD, introduce a new 200 mg strength, and reformulate the 100 mg strength to reduce injection site pain. Clinical studies (AMAG, AMAM) demonstrated mirikizumab's superiority over placebo in achieving clinical response and remission in CD, and non-inferiority to ustekinumab for clinical remission at Week 52. Pharmacokinetic analyses showed consistent profiles and no need for dose adjustments. Safety data aligned with its ulcerative colitis profile, with manageable risks including infections and liver injury. The CHMP recommended extending the marketing authorization for Omvoh in CD.
Key findings — cited to the page
| shifts to CTCAE Grade 3 or 4 for serum CK (mirikizumab) | 21 | · p.175 |
| Discontinuation rates of biologic treatments | up to 25 % | United States · p.11 |
| Marketing protection extension request status | withdrawn | · p.8 |
| Variation Type | IA | · p.6 |
| Study Phase | 3 | I6T-MC-AMAM · p.6 |
| Marketing protection extension requested | 1-year | · p.6 |
| Discontinuation rates of biologic treatments | 65 % | United States · p.11 |
| Scientific advice date | 22 June 2017 | · p.8 |
| Procedure start date | 23 May 2024 | · p.8 |
| CHMP positive opinion date | 12 December 2024 | Omvoh · p.8 |
| Crohn's disease prevalence | 322 cases per 100,000 persons | Germany · p.9 |
| Crohn's disease prevalence annual percentage change | 3.4 % | United States · p.9 |
Source: Eli Lilly and Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →