Novo Nordisk ( NYSE:NVO ) has secured approval from the European Medicines Agency (EMA) for a kidney disease-related label expansion for its blockbuster drug Ozempic (semaglutide) in Europe, on December 12th, 2024.

This label update allows Novo Nordisk to include information about reducing the risk of chronic kidney disease (CKD) events in adults with type 2 diabetes on Ozempic's label. The label expansion is based on results from the Phase III FLOW trial , which demonstrated significant benefits:

The 20% reduction in mortality risk for patients with chronic kidney disease (CKD) is a significant improvement, particularly given the high mortality rates associated with this condition. In the United States, an estimated 37 million adults have CKD, or about 1 in 7. Globally, more than 800 million people have CKD, which is more than 10% of the world's population. CKD patients face a substantially elevated risk of death compared to the general population, with cardiovascular mortality accounting for a large proportion of deaths in advanced stages of the disease. Patients with CKD often experience dramatically reduced life expectancy, and the overall survival rates for those on dialysis are worse than many cancers. Therefore, a 20% reduction in mortality risk can lead to increased life expectancy, improved quality of life, and a reduced burden on healthcare systems. However, even with this improvement, CKD patients still confront much higher mortality risks than the general population, highlighting the continuing need for ongoing efforts in early detection, management of comorbidities, and the development of new therapies to further enhance outcomes for these patients.

Ozempic (semaglutide) is now positioned to become the first GLP-1 ( glucagon-like peptide 1) receptor agonist approved for reducing the risk of kidney disease advancement in adults with type 2 diabetes and CKD. Novo Nordisk has also submitted a request for a similar label expansion in the United States, with a decision expected in 2025.

This development is significant because diabetes is the leading cause of kidney failure. The expanded indication could further boost the rapidly growing GLP-1 market, which some projections estimate could reach $111 billion by 2033 making them one of the most important recent drugs.