Novo Nordisk (NVO, Financial) announced that the European Medicines Agency's CHMP has given a positive opinion on updating the Ozempic (semaglutide) label to include information on reducing kidney disease-related risks. This decision is based on positive data from the FLOW renal outcome trial. Ozempic could become the first GLP-1 receptor agonist to lower the risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease (CKD). Novo Nordisk has also submitted a similar label expansion application to the U.S. FDA, with results expected in 2025.
The FLOW trial, a randomized, double-blind, placebo-controlled study, involved 3,533 patients with CKD and type 2 diabetes. It demonstrated that Ozempic significantly reduced the risk of kidney disease progression, cardiovascular, and kidney-related deaths by 24% compared to placebo. Secondary endpoints showed an 18% reduction in major cardiovascular events and a 20% reduction in all-cause mortality.
