FDA Expands Eli Lilly’s Mounjaro Use to Cut Cardiovascular Risk in Type 2 Diabetes

On August 28, the U.S. Food and Drug Administration approved Eli Lilly’s diabetes injection Mounjaro for reducing the risk of heart attack, stroke, and cardiovascular death in adults with type 2 diabetes who already have established heart disease. The agency’s decision adds a cardiovascular-risk indication to the drug, which already is used to control blood-sugar levels and is marketed for weight loss under the name Zepbound.

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The approval rests on a head-to-head trial involving more than 13,000 participants that compared Mounjaro with Lilly’s older diabetes medication Trulicity. The study found that patients taking Mounjaro experienced an 8% lower rate of major adverse heart events than those on Trulicity. Overall deaths from any cause were 16% lower among the Mounjaro group. While the trial met its primary goal of showing Mounjaro is at least as effective as Trulicity in protecting the heart, it did not demonstrate a statistically significant advantage beyond that benchmark.

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Lilly reported a 91% sales jump to $9.94 billion in the second quarter, reflecting strong demand for its GLP-1 franchise. Nevertheless, coverage for GLP-1 weight-loss drugs remains uneven. A Mercer survey indicated that about 6% of large employers plan to drop coverage of these medications in 2026, with an additional 5% expecting to do so in 2027. Insurers are more likely to continue covering GLP-1 agents when they are prescribed for type 2 diabetes, sleep apnea, or cardiovascular risk reduction.

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Beyond the approved indication, Lilly is pursuing late-stage studies on its oral obesity pill Foundayo for cardiovascular benefits and on the next-generation triple-hormone agonist retatrutide for weight loss, heart-event reduction, and kidney disease progression. Results from the retatrutide cardiovascular trial are not expected until 2027.

Reuters