FDA Approves Tirzepatide for Reducing Cardiovascular Risk in Adults with Type 2 Diabetes
The approval is based on a trial of 13,299 patients that found Mounjaro cut major cardiovascular events by 8% versus Trulicity, Lilly said.
- On Friday, August 28, 2026, the U.S. Food and Drug Administration approved Eli Lilly's Mounjaro to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these outcomes.
- The SURPASS-CVOT trial, the largest and longest tirzepatide study, prompted this approval after enrolling more than 13,000 participants across 30 countries over more than four and a half years.
- Trial data showed Mounjaro was non-inferior to Trulicity, demonstrating an estimated 8% lower risk of cardiovascular death, heart attack, or stroke over a median follow-up of 210.1 weeks. Superiority was not established.
- "Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event," said Dr. David A. D'Alessio, director of the Division of Endocrinology and Metabolism at Duke University School of Medicine.
- Kenneth Custer, Ph.D., executive vice president at Lilly Cardiometabolic Health, said the approval provides a proven way to lower heart disease risk, reinforcing Mounjaro's foundation beyond its existing A1C and weight management benefits.
19 Articles
19 Articles
The Independent (US)
Western Morning NewsEli Lilly diabetes drug wins FDA approval to lower cardiovascular risks
Heart disease is is the leading cause of death for people with Type 2 diabetes
Eli Lilly’s Mounjaro wins FDA approval for a major new cardiovascular benefit
Eli Lilly's Mounjaro received FDA approval for reducing heart attack and stroke risks. This new indication expands its use beyond diabetes and weight management. The drug demonstrated an 8% greater reduction in cardiovascular events in a key study. Mounjaro's approval strengthens Eli Lilly's position in the GLP-1 medicine market. This development highlights the expanding medical potential of these widely used drugs.
Mounjaro approved to reduce cardiovascular events in adults with diabetes
The FDA has approved tirzepatide for reduction of cardiovascular risk in adults with type 2 diabetes, Eli Lilly announced.Tirzepatide (Mounjaro), a dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, was already approved for improvement of glucose levels in patients with diabetes aged at least 10 years, and now has an indication for lowering risk for major adverse CV
Coverage Details
Bias Distribution
- 42% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
