💉 Eli Lilly has won FDA approval for Mounjaro to reduce the risk of major adverse cardiovascular events (MACE)—including cardiovascular death, heart attack and stroke—in adults with Type 2 diabetes, a population in which roughly one in three also has undetected cardiovascular disease. The label is underpinned by the phase 3 SURPASS-CVOT trial, a four-year, 13,000-patient study across 30 countries that marked the first head-to-head cardiovascular outcomes comparison between two incretin drugs rather than a placebo-controlled design. In SURPASS-CVOT, Mounjaro demonstrated non-inferiority to Lilly’s earlier GLP-1 franchise leader Trulicity and delivered an 8% lower rate of MACE versus Trulicity, which itself gained a cardiovascular-risk-reduction indication in 2020 after its 2014 diabetes approval
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