Eli Lilly and Company — Mounjaro EMA EPAR variation assessment report (EMEA/H/C/005620, 2022)
Eli Lilly and Company · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
Eli Lilly sought to expand Mounjaro's (tirzepatide) indication to include symptomatic chronic heart failure with preserved ejection fraction (HFpEF) in obese adults, based on the Phase 3 SUMMIT trial. Although a separate HFpEF indication was not approved, the CHMP supported incorporating SUMMIT trial data into the existing weight management indication. The SUMMIT trial demonstrated tirzepatide's efficacy in obese HFpEF patients, showing significant improvements in body weight, health-related quality of life (KCCQ-CSS, EQ-5D-5L), functional capacity, and reductions in HF events and inflammatory markers (hsCRP). While cardiovascular mortality was not reduced, cardiac biomarkers and function also improved. Safety data aligned with previous trials, with gastrointestinal adverse events (nausea, vomiting, diarrhea) being the most common, leading to higher discontinuation rates in the tirzepatide group. Pancreatitis and gallbladder events were also more frequent but rare. Overall, the benefit-risk balance was considered positive for improving HF-related outcomes within the context of weight management.
Key findings — cited to the page
| Scientific advice date | 18 October 2018 | · p.7 |
| LVEF for HFpEF diagnosis | 50 % or higher | · p.9 |
| Variation type | C.I.6.a - Change(s) to therapeutic indication(s) - Addition of a new therapeutic indication or modification of an approved one | · p.7 |
| Paediatric Investigation Plan (PIP) agreement number | P/0478/2023 | · p.7 |
| Scientific advice number | EMA/CHMP/SAWP/689326/2018 | · p.7 |
| Number of study centers | 129 | SUMMIT (Study I8F-MC-GPID) · Argentina, Brazil, China, India, Israel, Mexico, Russia, Taiwan, United States · p.31 |
| Global HFpEF prevalence | 32 million people | Global · p.9 |
| Application submission date | 11 November 2024 | · p.7 |
| Trial phase | Phase 3 | SUMMIT (Study I8F-MC-GPID) · p.7 |
| Trial design | randomized, multicenter, international, placebo-controlled, double-blind, parallel-arm study | SUMMIT (Study I8F-MC-GPID) · p.7 |
| Procedure Number | EMEA/H/C/005620/II/0038 | Mounjaro · p.1 |
| Variation type | C.I.6.a - Change(s) to therapeutic indication(s) - Addition of a new therapeutic indication or modification of an approved one | · p.8 |
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 →