Eli Lilly and Company — Mounjaro EMA EPAR public assessment report (EMEA/H/C/005620, 2022)
Eli Lilly and Company · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the assessment of Mounjaro (tirzepatide) for marketing authorization in Type 2 Diabetes Mellitus. It covers the drug's quality, manufacturing, and extensive non-clinical studies demonstrating its dual GLP-1 and GIP receptor agonism, dose-dependent glucose lowering, and weight reduction. Clinical pharmacology studies confirmed these effects, showing significant reductions in HbA1c, fasting plasma glucose, and body weight across five Phase 3 SURPASS trials, outperforming placebo and active comparators like semaglutide and insulin. Common adverse events were gastrointestinal, consistent with GLP-1 receptor agonists. While tirzepatide showed superior efficacy and a generally acceptable safety profile, uncertainties remain for specific patient subgroups, and cardiovascular benefit is still under investigation.
Key findings — cited to the page
| EC50 for cAMP production on human GLP2 receptor | 249 nM | QSB24 · p.33 |
| Tirzepatide EC50 of cAMP production (GIP and GLP1 receptors) | nanomolar or sub-nanomolar range | ENDO123 · p.20 |
| Regional Phase 3 studies duration (Japan) | 52 week | Mounjaro · Japan · p.11 |
| Phase 3 studies primary endpoint duration | 40- or 52-week | Mounjaro · p.11 |
| CHMP positive opinion for marketing authorisation | 21 July 2022 | Mounjaro · EU · p.8 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 30 April 2020 | Mounjaro · EU · p.6 |
| Phase 2 Study GPGB duration | 26 week | Mounjaro · p.11 |
| Tirzepatide multiple once-weekly dose range | 0.5 to 15 mg | Mounjaro · p.11 |
| Marketing authorization application submission date | 6 October 2021 | Mounjaro · EU · p.6 |
| Phase 2 Study GPGF duration | 12 week | Mounjaro · p.11 |
| Study GPGM treatment exposure duration | 104 weeks | Mounjaro · p.11 |
| Number of completed clinical studies | 19 | Mounjaro · 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 Metabolic library →