FDA Approves Semaglutide to Prevent Heart Events in Patients With CVD and Excess Weight

Semaglutide (Wegovy; Novo Nordisk) gained another indication, as the FDA expanded its approved uses to include prevention of cardiovascular death, myocardial infarction, and stroke in adult patients who have cardiovascular disease (CVD) and overweight or obesity.

The new indication was granted after a priority review process and was based on results from the SELECT cardiovascular outcomes trial (NCT03574597). Findings from SELECT showed that semaglutide significantly reduced the risk of major adverse cardiovascular events (MACE)—cardiovascular death, nonfatal myocardial infarction (heart attack), or nonfatal stroke)—by 20% compared with placebo when added to standard of care.

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