FDA Approves Mounjaro for Cardiovascular Risk Reduction

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.

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.