The FDA approved an expanded indication for Eli Lilly’s Mounjaro to reduce the risk of major adverse cardiovascular events (MACE). This approval applies to adults with type 2 diabetes and high cardiovascular risk.
The label expansion covers risks including cardiovascular death, heart attack, and stroke. Data from the SURPASS-CVOT trial supported the decision.
The study involved nearly 13,300 participants. Research for the trial spanned 30 countries.
Mounjaro is a dual GIP and GLP-1 receptor agonist. The new indication strengthens the drug's position in the rapidly growing diabetes and obesity markets.