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US approves Mounjaro to reduce cardiovascular risk

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Eli Lilly said on Friday the US 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.



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