The FDA has approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal heart attack or nonfatal stroke, in adults with type 2 diabetes who are at high risk for these events.
The approval was based on Surpass-Cvot, a trial that enrolled more than 13,000 participants across 30 countries over more than 4½ years, according to an Aug. 28 news release. Mounjaro performed at least as well as Trulicity (dulaglutide) in reducing the risk of cardiovascular death, heart attack or stroke. Patients taking Mounjaro had an 8% lower rate of these events than those taking Trulicity.
The approval follows a similar cardiovascular expansion the FDA granted Novo Nordisk’s Wegovy in 2024, making Mounjaro the latest GLP-1 to add a heart-protection indication on top of its original approval.
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