Tejal Somvanshi
The Food and Drug Administration approved Lilly’s Mounjaro on Friday to reduce the risk of cardiovascular death, heart attack, and stroke in adults with type 2 diabetes who are at high risk for these events.
Mounjaro is the first and only medicine to act as both a GIP and GLP-1 receptor agonist — hormones the gut produces to help control blood sugar — to receive FDA approval specifically for reducing cardiovascular risk in type 2 diabetes.
The approval is based on SURPASS-CVOT, a trial that compared Mounjaro directly against Trulicity, another Eli Lilly medicine with an established cardiovascular benefit. The trial enrolled 13,299 participants across 640 research sites in 30 countries and followed them for a median of 210.1 weeks, about four and a half years. The study is registered at ClinicalTrials.gov under identifier NCT04255433.
Mounjaro showed an 8% lower rate of major adverse cardiovascular events, or MACE, a combination of cardiovascular death, non-fatal heart attack, and non-fatal stroke. The hazard ratio was 0.92, with a 95.3% confidence interval of 0.83 to 1.01. Because the interval crossed 1.0, the trial showed Mounjaro was non-inferior to Trulicity but did not prove it was superior.
Kenneth Custer, president of Lilly Cardiometabolic Health, said the approval matters for patients. “For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro — the number one most prescribed branded type 2 diabetes medicine for adults in the U.S. — now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight,” Custer said.
Mounjaro is already the most-prescribed branded type 2 diabetes medicine for U.S. adults. The approval adds a cardiovascular indication to its existing use for blood sugar control.
Dr. David A. D’Alessio of Duke University School of Medicine, a co-author of the trial, noted that heart health needs attention across treatment. “Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” he said.
About one in three U.S. adults with type 2 diabetes have undetected cardiovascular disease, according to the approval document. The cardiovascular risk group targeted by this indication includes patients with established heart disease or multiple cardiovascular risk factors.
Safety data showed the most common side effects were gastrointestinal. These included nausea and vomiting and were typically mild to moderate. Most gastrointestinal effects occurred during the initial dose-escalation phase as patients moved slowly to their target dose.
The full trial results were published in the New England Journal of Medicine. Earlier, the FDA moved to end the tirzepatide shortage and phase out compounded versions, a shift that shaped access for patients. Medicare coverage of GLP-1 obesity drugs has also been under review, with Eli Lilly part of the discussion.
