FDA approves Lilly's Mounjaro to reduce cardiovascular risk in type 2 diabetes patients

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (trizepatide) to minimise the risk of major adverse cardiovascular events, including heart attack, stroke, and cardiovascular death, in adults with type 2 diabetes who are at high risk.

Lilly’s president of Cardiometabolic Health, Kenneth Custer, said: “For people with type 2 diabetes, heart disease is the leading cause of death. Mounjaro now gives them a proven way to lower that risk.”

The FDA’s approval decision is informed by findings from the cardiovascular outcome trial known as SURPASS-CVOT, which is the first cardiovascular outcomes trial to directly compare two incretin drugs rather than pitting them against placebo. The trial, conducted over five years and involving more than 13,000 patients in 30 countries, found that Mounjaro cut the risk of cardiovascular mortality, heart attack, or stroke by 8 per cent compared to Trulicity (dulaglutide).

The official statement reads: “Mounjaro is the first and only GIP and GLP-1 receptor agonist proven to lower heart attack, stroke or cardiovascular death risk in adults with type 2 diabetes at high risk for these events.”

The safety profile was consistent with previous studies, with gastrointestinal issues as the most frequent adverse reactions and usually mild to moderate.

There was a 91% increase in the sales of Mounjaro to $9.94 billion in the second quarter. The approval allows it to expand beyond managing diabetes and obesity and now include benefits in the prevention of cardiovascular disease among those with type 2 diabetes that make up one-third of the adult population in America.