ELI LILLY AND CO — Mounjaro (Autoinjector) FDA Review (NDA/BLA 215866, 2024)
Eli Lilly and Company · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval of Eli Lilly's Mounjaro (tirzepatide) autoinjector on July 28, 2023, for type 2 diabetes. It details the approved indication, dosage, contraindications, and warnings, including risks of thyroid C-cell tumors, pancreatitis, and hypoglycemia. Clinical trial data demonstrated Mounjaro's superior efficacy over semaglutide in reducing HbA1c, fasting glucose, and body weight. The report also covers the FDA's rigorous review process, including labeling changes for new vial presentations and updated safety information. Human factors studies identified user errors with the autoinjector, leading to recommendations for improved Instructions for Use. Extensive email correspondence between Eli Lilly and the FDA regarding labeling comments for NDA 215866 supplements is also documented.
Key findings — cited to the page
| FDA comments round | 3 | Mounjaro (tirzepatide) · United States · p.132 |
| FDA comments round | 2 | Mounjaro (tirzepatide) · United States · p.134 |
| Supplement S-002 receipt date | January 31, 2023 | Mounjaro (tirzepatide) · United States · p.132 |
| Supplement number | S-006 | Mounjaro (tirzepatide) · United States · p.132 |
| Supplement S-006 receipt date | April 18, 2023 | Mounjaro (tirzepatide) · United States · p.132 |
| Deadline for Lilly's response to FDA comments | July 24, 2023 | Mounjaro (tirzepatide) · United States · p.132 |
| Deadline for Lilly's response to FDA comments | July 13, 2023 | Mounjaro (tirzepatide) · United States · p.134 |
| Deadline for Lilly's response to FDA comments | June 23, 2023 | Mounjaro (tirzepatide) · United States · p.140 |
| NDA number | 215866 | Mounjaro (tirzepatide) · United States · p.151 |
| Supplement number | S-002 | Mounjaro (tirzepatide) · United States · p.151 |
| Supplement S-002 receipt date | January 31, 2023 | Mounjaro (tirzepatide) · United States · p.151 |
| FDA comments round | 1 | Mounjaro (tirzepatide) · United States · p.140 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →