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US FDA approves Lilly’s Mounjaro to reduce cardiovascular risk

By Thomson Reuters Aug 28, 2026 | 6:08 AM

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.

Mounjaro is the company’s diabetes drug that targets the GLP-1 protein and is also ‌used ​for weight loss. In the ⁠U.S., the obesity version ⁠is sold under the brand name Zepbound.

The 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 ⁠that 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.

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

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