Danish pharmaceutical company Novo Nordisk has received approval from the European Medicines Agency (EMA) to expand the labeling of its diabetes medication Ozempic. The updated label will now include the prevention of chronic kidney disease (CKD)-related events in adults with type 2 diabetes. This decision follows positive results from the phase III FLOW trial, which demonstrated Ozempic’s ability to slow CKD progression and reduce associated risks.
The FLOW trial, a randomized controlled study comparing Ozempic to placebo, was terminated early due to its strong efficacy. The results showed that Ozempic reduced all-cause mortality by 20% in patients with CKD compared to placebo. Additionally, major kidney disease events were reduced by 24%, and cardiovascular events decreased by 18% in the treated group. These findings suggest that patients taking Ozempic benefit not only from improved glycemic control but also from reduced risks of CKD and cardiovascular complications.
Diabetes is a leading cause of kidney failure, as persistently high blood sugar gradually damages blood vessels, according to the National Kidney Foundation. Ozempic addresses this dual challenge by targeting both glycemic control and the progression of kidney disease, making it a significant advancement in the treatment of type 2 diabetes.
Novo Nordisk is also pursuing a similar label expansion in the United States, with a decision from the FDA anticipated in the first quarter of 2025. Such developments are expected to solidify Ozempic’s position in the rapidly growing GLP-1 drug market, which is projected to reach $111 billion by 2033 as new therapeutic uses emerge for these medications beyond diabetes and obesity.
The competitive landscape in this market continues to intensify. Novo Nordisk has its own TREASURE-CKD trial underway for Zepbound (tirzepatide), a GIP/GLP-1 receptor agonist, aimed at treating obesity and CKD with or without type 2 diabetes. This trial is expected to conclude by mid-2026.
With the EMA’s approval, Ozempic becomes a crucial asset for Novo Nordisk in addressing diabetes and kidney disease, improving the quality of life for millions of patients worldwide.
