The regulatory decision follows data from the SURPASS-CVOT trial, the largest and longest study of tirzepatide to date. Over a median follow-up of four years, the trial monitored more than 13,000 participants across 30 countries. The results demonstrated that Mounjaro was non-inferior to Trulicity, showing an 8% lower rate of cardiovascular death, heart attack, or stroke in the patient population studied.
FDA Approves Mounjaro for Cardiovascular Risk Reduction
The U.S. Food and Drug Administration has granted approval for Eli Lilly’s Mounjaro to reduce the risk of major cardiovascular events, including heart attack and stroke, in adults with type 2 diabetes. This expansion of the drug's label addresses the leading cause of death among patients managing the condition.
Kenneth Custer, executive vice president of Lilly Cardiometabolic Health, noted that the company established a rigorous benchmark by testing the medication directly against a treatment with already proven cardiovascular benefits. While Mounjaro is already widely prescribed for glycemic control and weight management, this new indication provides a specific clinical pathway for high-risk diabetic patients to mitigate potential heart-related complications.
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