US FDA approves Lilly’s Mounjaro to reduce cardiovascular risk

Aug 28 (Reuters) – Eli Lilly said on Friday the U.S. FDA has approved its diabetes drug Mounjaro to reduce the chances of heart attack or stroke in adults with type 2 diabetes who are at high risk of cardiovascular events.

The approval expands the use of Mounjaro, which targets the GLP-1 protein, beyond blood sugar control. In the U.S., Lilly sells the obesity version of the drug under the brand Zepbound.

Lilly and Danish rival Novo Nordisk are both seeking to broaden the reach of their GLP-1 drugs, testing them in conditions ranging from cardiovascular disease to liver disorders.

Novo secured FDA approval for its weight-loss drug Wegovy for lowering heart risks in 2024 in overweight or obese adults without diabetes. In 2025, the FDA also approved its older diabetes drug, Rybelsus, to reduce the risk of major heart risks in diabetic patients.

Lilly’s approval was based on results from a trial that showed Mounjaro outperformed Trulicity, Lilly’s older diabetes drug, in reducing the risk of heart attack and stroke in a large, head-to-head study.

The trial showed Mounjaro reduced the risk of major adverse heart events by 8% more than Trulicity.

Sales of Mounjaro rose 91% to $9.94 billion during the second quarter as strong demand lifted sales volumes across global markets.

Lilly in April also said its oral obesity pill Foundayo was not inferior to a widely used long-acting insulin at lowering the risk of major heart problems in patients with type 2 diabetes and obesity.

The company is also conducting two separate late-stage studies: one on Foundayo’s cardiovascular benefits and another on its next-generation obesity drug retatrutide’s effects on cardiovascular events and kidney disease progression.

(Reporting by Sneha S K in Bengaluru; Editing by Shilpi Majumdar, Devika Syamnath and Jonathan Ananda)