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
This report summarizes the assessment of Omvoh (mirikizumab) for pediatric ulcerative colitis (UC) based on the open-label Phase 2 study I6T-MC-AMBU (SHINE-1). The study evaluated safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical response in 26 children and adolescents (2 to <18 years) with moderately to severely active UC. PK parameters were consistent with adult data, though no clear exposure-response relationship was established due to the small sample size. Efficacy showed a notable proportion of participants achieving clinical and endoscopic remission/response during induction and maintenance, particularly in biologic-naive patients. Common treatment-emergent adverse events (TEAEs) included COVID-19 and injection site pain, with a low rate of severe TEAEs and no deaths. The study informed the induction dosing for future pediatric Phase 3 studies based on weight categories, utilizing the same bioanalytical methods as adult studies.
Key findings — cited to the page
| Percentage of participants enrolled in Korea, Republic of | 15.4 % | Study AMBU · Korea · p.17 |
| Number of participants enrolled in Korea, Republic of | 4 | Study AMBU · Korea · p.17 |
| Procedure number | EMEA/H/C/005122/P46/004 | Omvoh (Mirikizumab) · p.1 |
| CHMP positive opinion date | 30/3/2023 | mirakizumab · p.4 |
| EC decision date | 26 May 2023 | mirikizumab (Omvoh) · p.4 |
| Study type | Phase 2 open label multicenter study | Study AMBU (SHINE-1) · p.5 |
| Study initiation date | May 2020 | Study AMBU · p.5 |
| Study completion date | March 2023 | Study AMBU · p.5 |
| Database lock date | 25 April 2023 | Study AMBU · p.5 |
| Number of participants planned to be screened | 60 | Study AMBU · p.5 |
| Number of participants planned to be enrolled | 30 | Study AMBU · p.5 |
| Minimum age of participants | 2 years | Study AMBU · p.7 |
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 →