Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes

The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk for these events.

Mounjaro, a dual GIP/GLP-1 receptor agonist, is the first drug of its class to demonstrate a cardiovascular benefit in this patient population, according to Lilly's press release.

The approval brings Lilly into direct competition with Novo Nordisk, whose semaglutide products Ozempic and Wegovy already have cardiovascular risk‑reduction indications for diabetes and obesity.

Mounjaro was previously approved as an adjunct to diet and exercise for improving blood‑sugar control in people aged 10 and older with type 2 diabetes, and the new label expands its use to cardiovascular protection.