FDA Approves Mounjaro to Cut Cardiovascular Risk in High-Risk Adults With Type 2 Diabetes

The U.S. Food and Drug Administration approved Mounjaro, or tirzepatide, to reduce the risk of cardiovascular death, nonfatal heart attack and nonfatal stroke in adults with type 2 diabetes who are at high risk. The decision relied on the 13,299-participant SURPASS-CVOT trial at 640 sites in 30 countries. Mounjaro was noninferior to Trulicity, with an observed 8% lower rate of the combined cardiovascular endpoint, although statistical superiority was not established. Lilly said safety findings were generally consistent with the medicine’s established profile, with gastrointestinal events the most common adverse effects.