Eli Lilly and Company — Omvoh EMA EPAR public assessment report (EMEA/H/C/005122, 2023)
Eli Lilly and Company · 2023 · EMA EPAR public assessment report · company profile →
Report summary
Eli Lilly Nederland B.V. applied for marketing authorization for Omvoh (mirikizumab) for moderately to severely active ulcerative colitis, receiving a positive EMA opinion in March 2023. Mirikizumab, an anti-IL-23 antibody, demonstrated superior efficacy over placebo in achieving clinical remission and other endpoints in both induction and maintenance phases of Phase 3 trials (AMAN and AMBG). Its manufacturing, quality, and non-clinical profiles were deemed acceptable. Pharmacokinetic analyses showed no need for dose adjustments based on patient factors, with low immunogenicity. Common adverse events included upper respiratory tract infections, rash, and headache. Safety concerns, such as elevated liver enzymes, serious infections, and potential cardiovascular risks, led to specific monitoring recommendations and a comprehensive risk management plan.
Key findings — cited to the page
| Grade 4 serum CK increase in placebo patients | 1 | · p.186 |
| Grade 4 serum CK increase in mirikizumab-treated patients | 11 | · p.186 |
| TEAEs of increased CK with higher CTCAE grade in mirikizumab group | 0.4 % | · p.186 |
| TEAEs of increased CK with higher CTCAE grade in placebo group | 0.6 % | · p.186 |
| Indication statement for Omvoh | Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy, or a biologic treatment or a Janus kinase (JAK) inhibitor, or have medical contraindications to such therapies (see section 5.1). | Omvoh · p.122 |
| Maternal pregnancies reported | 28 | · p.186 |
| IC50 for human IL-23 in functional activity assays | 82 pM | mirikizumab · p.24 |
| New active substance status | requested | mirikizumab · EU · p.8 |
| Binding affinity (KD) to human IL-23 | 21 pM | mirikizumab · p.24 |
| Proposed dosing regimen for induction | 300 mg IV Q4W for 12 weeks | mirikizumab · p.37 |
| Application submission date | 27 April 2022 | Omvoh (mirikizumab) · EU · p.8 |
| CHMP positive opinion date | 30 March 2023 | Omvoh (mirikizumab) · EU · p.10 |
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 →