INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY), a pharmaceutical company, announced Friday that the U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events.
Monjaro is the first and only GIP and GLP-1 receptor agonist proven to lower heart attack, stroke, or cardiovascular death risk in adults with type 2 diabetes at high risk for these events, in addition to its established A1C and weight loss benefits.
The drug, a dual GIP and GLP-1 hormone receptor agonist, was previously approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes.
The FDA approval was based on results from SURPASS-CVOT, the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo. The trial was the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years.
In the trial, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack, or stroke (MACE-3). The estimated hazard ratio for time to first MACE was 0.92 for Mounjaro compared to Trulicity.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
