FDA Expands Mounjaro Approval to Include Cardiovascular Benefits
On Aug. 28, the U.S. Food and Drug Administration approved Eli Lilly and Company’s Mounjaro to reduce the risk of major cardiovascular events, including heart attack, in adults with Type 2 diabetes. The drug was already authorized to help patients manage blood sugar.
Mounjaro, known generically as tirzepatide, acts on two incretin hormones, GLP-1 and GIP. These hormones are targets for medicines designed to control blood glucose and support weight loss. Lilly’s FDA submission compared Mounjaro with Trulicity, another company diabetes treatment that targets GLP-1 alone.
In the study, patients taking Mounjaro experienced an 8% lower rate of heart attack, stroke, or cardiovascular death than those receiving Trulicity. Earlier research found that Trulicity reduced cardiovascular events by 12% compared with placebo among people with and without a history of heart conditions. Because Trulicity already demonstrated cardiovascular benefits, Lilly described it as a relatively demanding comparator.
The findings do not permit a direct comparison with Novo Nordisk’s Ozempic or Wegovy because the studies used different designs and control groups. Ozempic, approved for diabetes, and Wegovy, approved for overweight and obesity, carry indications showing a 20% reduction in cardiovascular risk.
Lilly is also studying Zepbound, the weight-loss version of tirzepatide, in people who do not have Type 2 diabetes. That research is examining whether the drug can prevent first cardiovascular events and additional events among people who have already experienced one.
For patients with Type 2 diabetes who currently take Mounjaro, physicians can now discuss cardiovascular risk reduction alongside blood-sugar control. However, the available evidence does not establish the same heart benefit for people without diabetes using Zepbound solely for weight loss. Lilly expects results from its continuing study next year. Until then, treatment decisions will depend on approved indications, individual medical histories, and discussions between patients and health care professionals.