The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%.
Novo Nordisk received the go ahead to add a kidney disease–related expansion to Ozempic’s label in Europe. The Danish drugmaker said Thursday the European Medicines Agency (EMA) will allow a label update to its blockbuster GLP-1 to add an indication for lowering the risk of events related to chronic kidney disease in adults with type 2 diabetes.
Novo is expecting a decision from the FDA on a similar label expansion next month.
The EMA’s greenlight follows results from the Phase III FLOW trial, which ended early last October due to strong efficacy signals. The data, published earlier this year, showed that Ozempic lowered the risk of death from any cause by 20% versus placebo in patients with CKD. The primary endpoint of the study—major kidney disease events—was 24% lower in the Ozempic group than in the placebo group.
Additionally, cardiovascular events were 18% lower in the treatment group.
Diabetes is the top cause of kidney failure, according to the National Kidney Foundation. High levels of sugar in the blood over time cause damage to blood vessels.
Eli Lilly is currently testing its GIP/GLP-1 Zepbound (tirzepatide) in patients with obesity and CKD, with or without type 2 diabetes in the TREASURE-CKD trial. The trial is still recruiting with a completion date slated for early 2026.
Some projections estimate the GLP-1 market reaching $111 billion by 2033, particularly as companies continue to prove efficacy beyond diabetes and obesity.
