Novo Nordisk reports FDA approved label expansion for Wegovy

Novo Nordisk announced that the U.S. Food and Drug Administration has approved a label expansion for Wegovy based on a supplemental New Drug Application, or sNDA, for the indication of reducing risks of major adverse cardiovascular events, or MACE, including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease, or CVD. The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy statistically significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care. The exact mechanism of cardiovascular risk reduction has not been established.