The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk of heart problems.
The approval expands the use of Mounjaro, which is already approved along with diet and exercise to improve blood sugar levels in adults and children aged 10 years and older with type 2 diabetes.
Under the new approval, Mounjaro can be used to lower the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack and non-fatal stroke.
Heart disease is a leading cause of death among people with type 2 diabetes, making cardiovascular risk reduction an important part of diabetes care. Eli Lilly said the new approval adds cardiovascular benefits to Mounjaro’s existing effects on blood sugar control and weight management.
The FDA decision was based on results from the SURPASS-CVOT study, which compared Mounjaro directly with Trulicity (dulaglutide), a GLP-1 medicine with established cardiovascular benefits.
The trial included more than 13,000 participants across 30 countries and lasted more than four and a half years. It was the first cardiovascular outcomes study to directly compare two incretin medicines rather than comparing a treatment with a placebo.
In the study, Mounjaro was shown to be non-inferior to Trulicity for reducing major cardiovascular events. Participants receiving Mounjaro experienced an 8% lower rate of cardiovascular death, heart attack or stroke compared with those receiving Trulicity.
The estimated hazard ratio for the time to the first MACE was 0.92, with a 95.3% confidence interval of 0.83 to 1.01.
Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health, said the company aimed to generate strong evidence by comparing Mounjaro with a diabetes medicine already known to provide cardiovascular benefits.
Researchers involved in the study also highlighted the importance of addressing heart health alongside blood sugar control in people with type 2 diabetes.
The safety profile of Mounjaro in SURPASS-CVOT was generally consistent with what has already been seen with the medicine. The most common side effects were gastrointestinal problems, which were generally mild to moderate and occurred mainly while doses were being increased.
The expanded FDA approval gives physicians another option for managing both diabetes and cardiovascular risk in high-risk adults. It also strengthens the clinical evidence supporting tirzepatide as a treatment for type 2 diabetes with benefits extending beyond blood sugar control.