LLY · News · 20260828N
Regulatory Approval Milestones
ELI LILLY & Co · 2026-08-28 · Importance 53 · Surprise 60 · In source text
On August 28, 2026, the U.S. Food and Drug Administration approved Lilly’s Mounjaro (tirzepatide) to reduce major adverse cardiovascular events in adults with type 2 diabetes at high risk. The expanded indication covers cardiovascular death, non-fatal heart attack, and non-fatal stroke. Mounjaro retains its existing U.S. approval for improving blood sugar in adults and children aged 10 and older with type 2 diabetes, while the new cardiovascular indication could broaden its addressable market and reimbursement support.
Key facts
- The U.S. Food and Drug Administration approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events (announced Aug. 28, 2026). source
- Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | The U.S. Food and Drug Administration approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular (CV) events… |