Novo Nordisk A/S announced on 26 July 2024 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a “positive opinion” for an update to the label of Wegovy® (semaglutide 2.4 mg) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes. This update reflects the findings of the SELECT cardiovascular outcomes trial which demonstrated a significant 20% reduction in major adverse cardiovascular events. Novo Nordisk expects implementation of the label update within approximately one month.
The update also aligns with the US FDA approved label expansion for Wegovy® in March 2024.