Eli Lilly's Mounjaro Wins FDA Approval to Reduce Cardiovascular Risk in Type 2 Diabetes

07:28 AM EDT, 08/28/2026 (MT Newswires) -- Eli Lilly (LLY) said Friday that the US Food and Drug Administration approved Mounjaro to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for those events. The company said the events include cardiovascular death, non-fatal heart attack, or non-fatal stroke. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children ages 10 and older with type 2 diabetes. The FDA's approval was based on results from the SURPASS-CVOT Phase 3 trial evaluating the efficacy and safety of Mounjaro compared with Eli Lilly's Trulicity in adults with type 2 diabetes and established atherosclerotic cardiovascular disease, the company said. Shares of Eli Lilly were up 1.1% pre-bell.