Eli Lilly and Company — Lyumjev (previously Liumjev) EMA EPAR public assessment report (EMEA/H/C/005037, 2020)
Eli Lilly and Company · 2020 · EMA EPAR public assessment report · company profile →
Report summary
This EMA assessment report details the marketing authorization for Lyumjev (insulin lispro), an ultra-rapid-acting insulin by Eli Lilly, for adult diabetes treatment. Manufacturing, characterization, and the role of excipients like treprostinil in accelerating absorption are described. Non-clinical and clinical studies consistently demonstrate Lyumjev's faster insulin absorption and earlier glucose-lowering effects compared to Humalog, with similar overall insulin exposure. Pivotal Phase 3 trials (PRONTO-T1D, PRONTO-T2D, PRONTO-Pump) showed Lyumjev's non-inferiority to Humalog in HbA1c reduction and superiority in controlling postprandial glucose excursions in both Type 1 and Type 2 diabetes. While overall safety profiles were comparable, Lyumjev exhibited a higher incidence of injection site reactions and different hypoglycemia timing. The benefit-risk ratio was deemed positive, leading to a recommended marketing authorization.
Key findings — cited to the page
| Local irritation at injection or infusion sites | 2 % | · p.174 |
| Number of healthy subjects | 28 | I8B-FW-ITRA (ITRA) · p.32 |
| Total patients receiving study drug (LY900014 or Humalog) in Phase 3 studies | 1944 | LY900014 · p.12 |
| Non-inferiority margin for FDA Phase 3 studies | 0.4 % | United States · p.12 |
| Marketing authorization application submission date | 8 March 2019 | Liumjev · EU · p.6 |
| Number of T1D or T2D patients exposed to LY900014 in clinical pharmacology trials | 342 | LY900014 · p.12 |
| Procedure start date | 28 March 2019 | · p.9 |
| Patients receiving LY900014 in Phase 3 studies | 1165 | LY900014 · p.12 |
| Non-inferiority margin for EU Phase 3 studies | 0.3 % | EU · p.12 |
| CHMP positive opinion date | 30 January 2020 | · p.9 |
| Number of healthy subjects exposed to LY900014 in clinical pharmacology trials | 421 | LY900014 · p.12 |
| Number of T2D patients | 22 | F3Z-MC-IOEK (IOEK) · p.33 |
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 →