Eli Lilly and Company — Mounjaro FDA Review (NDA215866, ORIG 1, 2022)
Eli Lilly and Company · 2022 · FDA Review (openFDA) · company profile →
Report summary
The FDA recommends approval for Eli Lilly's Mounjaro (tirzepatide) for glycemic control in adults with type 2 diabetes, adjunct to diet and exercise. This injectable GIP and GLP-1 receptor agonist, administered once-weekly, demonstrated significant HbA1c and body weight reductions in five Phase 3 trials (SURPASS-1 to SURPASS-5). The review covered its mechanism, pharmacokinetics, and nonclinical safety, including thyroid C-cell hyperplasia/neoplasia in rats. While efficacy was robust, safety findings included gastrointestinal adverse events, gallbladder disorders, and potential thyroid safety concerns, leading to specific labeling and postmarketing requirements, including a 15-year medullary thyroid carcinoma surveillance study. Overall, the safety profile was deemed acceptable for approval.
Key findings — cited to the page
| Percentage of adult diabetics in US using metformin as single antihyperglycemic medication (2008-2015) | 51 % | US · p.29 |
| Elimination half-life (T1/2) | 5 days | Tirzepatide · p.57 |
| Metabolites in circulating radioactivity | <5.7% | Tirzepatide · p.57 |
| Metabolite elimination in urine | 50% | Tirzepatide · p.57 |
| Metabolite elimination in feces | 20% | Tirzepatide · p.57 |
| AUCtau reduction of ethinyl estradiol with tirzepatide | 21% | Tirzepatide · p.57 |
| AUCtau reduction of norelgestromin with tirzepatide | 23% | Tirzepatide · p.57 |
| AUCtau reduction of norgestimate with tirzepatide | 21% | Tirzepatide · p.57 |
| Cmax reduction of ethinyl estradiol with tirzepatide | 59% | Tirzepatide · p.57 |
| Cmax reduction of norelgestromin with tirzepatide | 55% | Tirzepatide · p.57 |
| Cmax reduction of norgestimate with tirzepatide | 66% | Tirzepatide · p.57 |
| Percentage of adult diabetics in US using single antihyperglycemic medication (2008-2015) | 56 % | US · p.29 |
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 →