Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPAR variation assessment report (EMEA/H/C/005037, 2020)
Eli Lilly and Company · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
Eli Lilly sought to extend Lyumjev's (insulin lispro) indication for diabetes treatment in children and adolescents aged 1 year and above. Based on the pivotal Phase 3 study I8B-MC-ITSB, Lyumjev demonstrated non-inferiority to Humalog in glycemic control (HbA1c) in pediatric patients with Type 1 Diabetes, both pre- and post-meal. Pharmacokinetic/pharmacodynamic studies confirmed accelerated insulin absorption with Lyumjev. While overall safety was comparable to Humalog, Lyumjev showed a higher rate of severe hypoglycemia in the 3 to <6 years age group and more frequent, though generally mild, injection site reactions. Despite these findings, the CHMP concluded a positive benefit-risk balance for Lyumjev in this pediatric population.
Key findings — cited to the page
| Treprostinil exposure safety margin (reproduction and developmental toxicity studies) | 415 fold | · p.12 |
| Number of centers | 96 | United States, Russia, Czech Republic, Spain, Ukraine, Brazil, Israel, France, Italy, Poland, United Kingdom, Mexico, China, Austria, Germany, Denmark, Japan · p.70 |
| Market Protection Request | 1 year | · p.6 |
| Requested Indication Extension Age | 1 year and above | Lyumjev · p.6 |
| Submission Date | 22 December 2021 | Lyumjev · p.6 |
| Primary Endpoint | change in HbA1c | I8B-MC-ITSB · p.6 |
| CHMP Opinion Date | 13 October 2022 | · p.7 |
| Market Protection Request Status | withdrawn | · p.6 |
| Scientific Advice Sought | No | · p.6 |
| Treprostinil amount in Lyumjev | 10 ng/U | Lyumjev · p.11 |
| Study Type | Pivotal Phase 3 study | I8B-MC-ITSB · p.6 |
| Procedure Number | EMEA/H/C/005037/II/0014 | Lyumjev · p.1 |
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 Metabolic library →