European Ozempic Label Will Include Kidney Disease Indication

On December 12, Danish drug maker Novo Nordisk announced that the European Medicines Agency approved an addition to the label of its blockbuster drug Ozempic (once-weekly subcutaneous semaglutide). The label will be updated to add risk reduction for events related to kidney disease.

The decision stems from positive results of the FLOW trial, which examined risk reduction from Ozempic therapy in chronic kidney disease (CKD)-related events. The trial found that semaglutide 1.0 mg demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression as well as cardiovascular and kidney death compared to placebo. In addition, semaglutide reduced the risk of major cardiovascular events by 18% and the risk of all-cause mortality by 20%.

Novo Nordisk has filed for a label expansion in the United States and expects a decision in the first half of 2025.