Novo Nordisk's Wegovy® approved by FDA for reducing cardiovascular event risks

Novo Nordisk (NVO) has announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy®, a treatment for reducing risks of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease. The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy® significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care. The label is updated to include data showing a risk reduction in cardiovascular death by 15% and a risk reduction of death from any cause by 19%, compared to placebo. The therapy is now approved in the US, and a decision on a label expansion in the EU is expected in 2024.