FDA approves Eli Lilly's Mounjaro to reduce heart attack and stroke risk

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s diabetes medication, Mounjaro, to reduce the risk of heart attack, stroke, and cardiovascular death in adults with Type 2 diabetes and high cardiovascular risk.

The approval expands the drug's therapeutic use beyond glycemic control and obesity management. The decision follows a clinical study involving over 13,000 patients, which demonstrated that Mounjaro, containing the active substance tirzepatide, reduced the rate of serious cardiovascular events by 8% compared to the older drug Trulicity.

Tirzepatide works by targeting both GIP and GLP-1 hormone receptors to regulate blood sugar and appetite. This development occurs amid intense competition in the GLP-1 receptor agonist market, as manufacturers like Eli Lilly and Novo Nordisk seek to expand the applications of these medications. Analysts project the global market for weight-loss and metabolic medications could reach approximately $105 billion by 2030.