FDA approves Mounjaro to lower heart attack, stroke and CV death risk in type 2 diabetes

The FDA approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke in adults with type 2 diabetes who are at high risk of these events, Eli Lilly announced. The approval rests on SURPASS-CVOT, which randomised 13,299 people to tirzepatide or to dulaglutide (Trulicity), a GLP-1 medicine with established cardiovascular benefit, rather than to placebo: tirzepatide was non-inferior, with a hazard ratio of 0.92 (95.3% CI 0.83 to 1.01), so it was not shown to be better than dulaglutide. The EMA's CHMP declined the same indication in June 2026, so the US and EU labels now differ.