Eli Lilly's Mounjaro Receives FDA Approval to Reduce Cardiovascular Risk in Type 2 Diabetes Patients
Eli Lilly's Mounjaro (tirzepatide) has received U.S. FDA approval to reduce the risk of cardiovascular death, heart attack, or stroke in adults with type 2 diabetes (T2D) who are at high risk for these cardiovascular events. This approval makes Mounjaro the first dual GIP and GLP-1 receptor agonist to achieve this indication. Mounjaro was already approved for improving blood sugar in T2D patients. The new approval is supported by data from the SURPASS-CVOT trial, which involved 13,000 participants over more than four and a half years. The trial compared Mounjaro to Lilly's Trulicity, a GLP-1 treatment with established cardiovascular benefits, demonstrating Mounjaro's non-inferiority and an 8% lower rate of major adverse cardiovascular events (MACE-3) compared to Trulicity.