US FDA approves Lilly's Mounjaro to reduce cardiovascular risk
LLY•Trial results and sales context
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.
Novo Nordisk approvals and broader GLP-1 competition
Danish rival Novo Nordisk NOVOb.CO 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.
FDA approves Mounjaro for cardiovascular risk reduction
Eli Lilly LLY.N 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.
