Mounjaro gains FDA approval to reduce cardiovascular risk in type 2 diabetes

The US Food and Drug Administration has expanded its approval of Mounjaro, allowing the diabetes medicine to be used to reduce the risk of major cardiovascular events in adults with type 2 diabetes who face high cardiovascular risk. These events include cardiovascular death, nonfatal heart attack and nonfatal stroke.

The decision was based on the SURPASS-CVOT trial, which followed more than 13,000 participants across 30 countries for about four and a half years. Researchers compared Mounjaro, also known as tirzepatide, with Trulicity, or dulaglutide, an established diabetes treatment with proven cardiovascular benefits.

Mounjaro was found to be at least as effective as Trulicity at preventing major adverse cardiovascular events. The estimated risk was 8% lower among participants receiving Mounjaro, although the trial’s central finding was that it was not inferior to the comparison medicine. Its safety profile remained consistent with earlier research. Most adverse events were mild to moderate gastrointestinal problems that occurred while doses were being increased.

Mounjaro was already approved to help control blood glucose. The new indication means one treatment can now address metabolic health while also reducing serious cardiovascular risk, an important concern because people with type 2 diabetes are more vulnerable to heart disease and stroke.