FDA Approves Drug to Reduce Heart Attack Risk in People With Type 2 Diabetes
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of serious cardiovascular events in adults with type 2 diabetes.
The approval means Mounjaro can now be used to lower the risk of heart attack, stroke and cardiovascular death in these patients.
The decision was supported by results from SURPASS-CVOT, a major cardiovascular study that compared Mounjaro directly with Trulicity (dulaglutide).
The study followed more than 13,000 patients in 30 countries for five years. Results showed that patients taking Mounjaro had an 8% lower risk of cardiovascular death, heart attack or stroke compared with Trulicity.
Unlike cardiovascular trials that compare a treatment with a placebo, SURPASS-CVOT directly compared two incretin-based medicines.
Kenneth Custer, president of Cardiometabolic Health at Eli Lilly, said heart disease is the leading cause of death in people with type 2 diabetes. He said Mounjaro can now help these patients lower that risk.
Lilly said Mounjaro is the first and only medicine to target both GIP and GLP-1 receptors and reduce cardiovascular risk. It lowers the risk of heart attack, stroke and cardiovascular death in high-risk adults with type 2 diabetes.
The study did not identify any major new safety concerns. The safety results were in line with previous Mounjaro studies, while gastrointestinal problems remained the most commonly reported side effects. Most were mild to moderate.
The FDA approval expands Mounjaro’s benefits for adults with type 2 diabetes. The drug can now also help reduce the risk of serious cardiovascular events.
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