FDA approves Mounjaro to cut heart attack and stroke risk in type 2 diabetes patients for the FIRST TIME

The US Food and Drug Administration has approved Eli Lilly's diabetes drug Mounjaro to lower the risk of heart attack, stroke and cardiovascular death in type 2 diabetes patients with elevated cardiovascular risk. The approval makes Mounjaro the first and only dual GIP and GLP-1 receptor agonist to carry a cardiovascular risk-reduction label, alongside its existing indications for blood sugar control and weight loss. The decision follows a four-and-a-half-year trial enrolling over 13,000 people across 30 countries. Mounjaro beat rival drug Trulicity in cutting major adverse heart events by 8 per cent.

Cardiovascular disease is the leading cause of death among people with type 2 diabetes, and around one in three US adults living with the condition may not know they have it.

The trial broke new ground as the first to set two incretin therapies against each other head-to-head rather than against a placebo, substantially raising the standard of evidence.

Mounjaro already leads all branded type 2 diabetes medicines in prescription volume among US adults, meaning millions of current patients could stand to benefit from the expanded indication.