Eli Lilly’s Mounjaro (tirzepatide) secures expanded US approval to lower major cardiovascular events in adults with type 2 diabetes at high risk of heart disease, marking a significant shift in diabetes management practices.
Eli Lilly’s Mounjaro has won expanded US approval to cut the risk of serious cardiovascular events in adults with type 2 diabetes who are at high risk of heart disease, adding a heart-protection claim to a drug already used to improve blood sugar control. The move by the US Food and Drug Administration broadens the medicine’s role beyond diabetes management and weight-related benefits, giving doctors another option for patients whose treatment plans must also address cardiovascular risk.
According to the company and reports of the approval, the new indication covers the prevention of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack and non-fatal stroke. Mounjaro, which contains tirzepatide, was already approved with diet and exercise to improve glycaemic control in adults and children aged 10 and older with type 2 diabetes.
The FDA decision was based on the SURPASS-CVOT study, a large trial that directly compared Mounjaro with Trulicity, another diabetes medicine with established cardiovascular benefits. Eli Lilly said the study involved more than 13,000 people in 30 countries and ran for more than four and a half years, making it the first cardiovascular outcomes trial to pit two incretin medicines against each other rather than using a placebo. The company said Mounjaro was non-inferior to Trulicity, with an 8% lower rate of cardiovascular death, heart attack or stroke, and a hazard ratio of 0.92.
The safety findings were broadly in line with Mounjaro’s existing profile, with gastrointestinal side effects remaining the most common and generally appearing during dose increases. Kenneth Custer, Eli Lilly’s cardiometabolic health chief, said the company wanted to generate strong evidence by comparing Mounjaro with a drug already known to protect the heart, underscoring the growing emphasis in type 2 diabetes care on treating blood sugar and cardiovascular risk together.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
