US FDA approves semaglutide (Wegovy) to reduce risk of cardiovascular events in adults with cardiovascular disease who are obese or overweight
Expanded approval for the GLP-1 agonist was based on results of the Phase III SELECT trial (n=17,604) in which its addition to standard medical treatment and lifestyle counselling reduced the risk of major cardiovascular events (6.5% vs. 8% placebo; 95% CI 0.72-0.90; p<0.001).
Source:
US Food and Drug Administration
SPS commentary:
Results from the Phase III SELECT trial were published in the NEJM in November 2023. Novo Nordisk has also filed for a label expansion in the European Union, with a decision expected in 2024.