The FDA has approved Eli Lilly’s tirzepatide (Mounjaro) to reduce cardiovascular risk in adults with type 2 diabetes, based on results from SURPASS-CVOT. The outcomes trial compared tirzepatide head-to-head with dulaglutide and showed non-inferiority for major adverse cardiovascular events (MACE-3). The decision adds another indication to a drug already established for glycemic control and weight loss. The FDA action follows growing scrutiny and interest in CV outcomes across incretin-based therapies, particularly as manufacturers broaden labels to earlier lines of intervention.