The FDA has approved Eli Lilly’s tirzepatide (Mounjaro) to reduce cardiovascular risk in adults with type 2 diabetes, extending the drug’s label beyond glycemic control and weight loss. The decision is based on the SURPASS-CVOT cardiovascular outcomes trial, which compared tirzepatide head-to-head with dulaglutide. In SURPASS-CVOT, tirzepatide demonstrated non-inferiority on time to first major adverse cardiovascular event and showed an 8% lower rate of MACE-3 versus dulaglutide, according to the company’s reported results. Safety findings were described as consistent with the established tirzepatide profile, with gastrointestinal adverse events dominating during dose escalation. This approval places another incretin therapy on a direct cardiovascular outcomes footing and reinforces the shift toward cardiometabolic endpoints as core evidence in diabetes drug differentiation.