On 12 December 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events.
The EMA will therefore allow Novo Nordisk to add risk reduction for events related to kidney disease to the label of its diabetes drug Ozempic®.