FDA Approves First Treatment to Reduce Risk of Major Adverse CV Events, Specifically in Adults with Obesity or Overweight

11 Mar 2024 • The FDA has approved a new indication for the use of semaglutide: to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease (CVD) and either obesity or overweight. Semaglutide (2.4mg) is the first weight-loss medication approved for this specific purpose.

The approval was based on efficacy and safety in the multicentered, placebo controlled, double-blind SELECT trial, which had over 17,600 individuals in the cohort. The findings from the SELECT trial showed that the risk of MACEs was reduced by 20% compared with the placebo in combination with standard of care.

This marks the first-and-only treatment indicated for both the reduction of the risk of MACEs, such as CV death, heart attack, or stroke & for long-term weight management.

It is indicated for use in combination with a low-calorie diet and increased physical activity.

Source: US FDA | Read full story

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