Key Takeaways:
The FDA approved Eli Lilly's Mounjaro (tirzepatide) to cut cardiovascular risk 8%, expanding the drug's use in adults with type 2 diabetes.
"For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight," Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said.
The approval rests on SURPASS-CVOT, a trial of 13,299 participants across 640 sites in 30 countries followed for a median of 210.1 weeks. Mounjaro showed an 8 percent lower rate of cardiovascular death, heart attack or stroke (MACE-3) versus Trulicity (dulaglutide), with a hazard ratio of 0.92 (95.3% CI: 0.83, 1.01). Superiority over dulaglutide was not established. It was the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against placebo.
Mounjaro is the first and only GIP and GLP-1 receptor agonist proven to lower cardiovascular risk in this population, and the #1 most prescribed branded type 2 diabetes medicine for adults in the U.S. As many as one in three U.S. adults with type 2 diabetes have undetected cardiovascular disease, according to Lilly.
"Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event," David A. D'Alessio, study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine, said. "While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked."
The safety profile was consistent with Mounjaro's established label. The most common adverse events in SURPASS-CVOT were gastrointestinal-related, generally mild-to-moderate, occurring mainly during dose escalation. Full results were published in the New England Journal of Medicine.
The expanded indication gives Lilly a fresh growth driver for Mounjaro, its top-selling metabolic drug, and strengthens its competitive position against Novo Nordisk in the GLP-1 market. Regulatory submissions based on SURPASS-CVOT are under review in additional markets, and the data has been added to Mounjaro's product information in the European Union.
This article is for informational purposes only and does not constitute investment advice.
