The U.S. Food and Drug Administration has approved Eli Lilly's drug Mounjaro for a new indication: reducing the risk of major cardiovascular events in adults with Type 2 diabetes. This marks a significant expansion for the medication, which is already available for managing diabetes and, in its different formulation as Zepbound, for weight loss.
Cardiovascular disease is a leading cause of death for individuals with Type 2 diabetes. The approval is based on findings from a study that demonstrated Mounjaro's efficacy in mitigating heart risks within this patient population. "This study was in patients with Type 2 diabetes, in whom the No. 1 cause of death is cardiovascular disease," said Dr. Rachel Batterham, senior vice president of medical innovation and external engagement for cardiometabolic health at Lilly. "So reducing that risk is critically important."
Lilly set a high benchmark for the study, comparing Mounjaro's cardiovascular benefit against Trulicity, another drug already established to reduce heart risk. However, the study design prevents a direct comparison of these results with Mounjaro's competitor, Ozempic, from Novo Nordisk, which also holds an indication for lowering heart disease risk by 20%. Novo Nordisk's Wegovy, a related drug, is also approved for treating obesity and carries a similar cardiovascular risk reduction indication.
Eli Lilly is currently conducting a separate study focused on Zepbound, the weight-loss formulation of their drug, in individuals who do not have Type 2 diabetes. This ongoing research aims to determine if Zepbound can prevent both first and subsequent heart events in a broader population.