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Eli Lilly's Mounjaro Wins FDA Approval to Reduce Cardiovascular Risk in Type 2 Diabetes

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Eli Lilly (LLY) said Friday that the US Food and Drug Administration approved Mounjaro to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for those events.

The company said the events include cardiovascular death, non-fatal heart attack, or non-fatal stroke.

Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children ages 10 and older with type 2 diabetes.

The FDA's approval was based on results from the SURPASS-CVOT Phase 3 trial evaluating the efficacy and safety of Mounjaro compared with Eli Lilly's Trulicity in adults with type 2 diabetes and established atherosclerotic cardiovascular disease, the company said.

Shares of Eli Lilly were up 1.1% pre-bell.

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