Novo Nordisk Secures Approval for Ozempic’s Kidney Disease Expansion in European Markets

Novo Nordisk has been granted permission to expand the label for Ozempic in Europe to include chronic kidney disease indications. On Thursday, the Danish pharmaceutical company announced that the European Medicines Agency (EMA) approved an update to its prominent GLP-1 medication to encompass lowering the risk of events associated with chronic kidney disease in adults diagnosed with type 2 diabetes.

Novo is awaiting feedback from the FDA regarding a similar label expansion, anticipated next month.

The EMA’s decision comes after encouraging outcomes from the Phase III FLOW trial, which was concluded prematurely last October due to notable efficacy findings. The results, published earlier this year, indicated that Ozempic reduced all-cause mortality risk by 20% compared to placebo among patients with chronic kidney disease (CKD). The primary outcome—major kidney disease events—was 24% decreased in the Ozempic cohort relative to the placebo group.

Furthermore, cardiovascular incidents were seen to be 18% less frequent within the treatment group.

The National Kidney Foundation identifies diabetes as the leading reason for kidney failure. Chronic high blood sugar levels can damage blood vessels significantly over time.

Eli Lilly is currently advancing the GIP/GLP-1 Zepbound (tirzepatide) in a trial focused on patients with obesity and CKD, with or without concurrent type 2 diabetes, known as the TREASURE-CKD study. This trial is still in the recruiting phase and has a completion deadline projected for early 2026.

Current projections suggest that the GLP-1 market could reach 1 billion by 2033, especially as companies validate their efficacy for conditions beyond diabetes and obesity.