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FDA expands Mounjaro approval for heart attack and stroke prevention

The FDA expanded approval of Eli Lilly's Mounjaro for high-risk adults with type 2 diabetes.
FDA expands Mounjaro approval for heart attack and stroke prevention
Eli Lilly-Manufacturing Expansion
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The Food and Drug Administration is expanding the use of the diabetes drug Mounjaro to help prevent heart attacks and strokes in high-risk adults with type 2 diabetes.

The new approval applies to the drug produced by Eli Lilly.

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Kenneth Custer, president of Lilly Cardiometabolic Health, said the expansion builds on the drug's existing track record.

"For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the #1 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. "We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field."

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Lilly says Mounjaro reduced major cardiovascular events by an additional 8% compared to its older diabetes drug Trulicity. The same medication is prescribed for weight loss under the name Zepbound.

Eli Lilly researchers say they are now testing newer drugs that target even more hormones.