The U.S. Food and Drug Administration (FDA) approved Eli Lilly's Mounjaro to reduce major cardiovascular risks in adults with type 2 diabetes. This label expansion targets patients with high cardiovascular risk to lower the occurrence of heart attacks and strokes. Mounjaro is now the first and only dual GIP and GLP-1 receptor agonist with an FDA-cleared claim for heart risk reduction.
The SURPASS-CVOT clinical trial supported the approval with data from over 13,000 participants. The study spanned 30 countries to evaluate the drug's efficacy. Results demonstrated that Mounjaro lowered heart-related event rates more effectively than Lilly's older drug, Trulicity. Analysts expect the new indication to increase Mounjaro's sales and improve insurance coverage.