Lilly’s Mounjaro Wins Approval to Reduce Cardiovascular Risk

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s diabetes treatment Mounjaro for reducing the risk of cardiovascular disease.

According to Fierce Pharma on the 28th local time, the FDA approved Mounjaro for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes. MACE includes cardiovascular death, myocardial infarction and stroke.

With this approval, Lilly has reached the same level as the cardiovascular risk-reduction indication secured by Novo Nordisk in 2020 for its diabetes treatment Ozempic. Ozempic expanded its indication three years after its initial approval, while Mounjaro did so after four years.

Lilly said that one in three people with type 2 diabetes also has undiagnosed cardiovascular disease.

The approval is significant because it was based on the results of the first head-to-head clinical trial between incretin-class drugs, rather than a placebo-controlled trial.

In the phase 3 trial (SURPASS-CVOT), conducted for more than four years in 13,000 people across 30 countries, Mounjaro reduced the incidence of cardiovascular death, myocardial infarction and stroke by 8% compared with Lilly’s existing diabetes treatment Trulicity. Trulicity was approved as a treatment for type 2 diabetes in 2014 and added a cardiovascular risk-reduction indication in 2020.

Novo Nordisk’s Ozempic was approved based on the results of the SUSTAIN 6 trial, which showed a 26% reduction in the risk of cardiovascular events compared with placebo.

Kenneth Custer, head of Lilly’s cardiometabolic health division, said, "We set a higher bar by comparing Mounjaro with a GLP-1-class drug with proven cardiovascular benefits."

This is Mounjaro’s first indication expansion. Lilly’s obesity treatment Zepbound, which contains the same active ingredient as Mounjaro (tirzepatide), received an additional approval for a sleep apnea indication in 2024.