FDA Greenlights Expanded Use of Ozempic

Already a household name in diabetes care – and a key player in the weight loss market under its sister brand Wegovy – Ozempic now holds the broadest GLP-1 receptor agonist (GLP-1 RA) indication on the market. In addition to its use for type 2 diabetes, Ozempic may now also be used to reduce the risk of worsening kidney disease, kidney failure and death from cardiovascular disease in patients with chronic kidney disease and diabetes. According to Novo Nordisk, about 40 percent of patients with type 2 diabetes also suffer from kidney disease. “Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities,” said Anna Windle, Senior Vice President Clinical Development, Medical & Regulatory Affairs at Novo Nordisk.

The approval is based on the company’s FLOW study, which found that Ozempic reduced the risk of severe kidney damage by 24% compared to placebo.

Despite the expanded approval, investors remained unmoved. While Novo Nordisk is working to scale up production, investing in new manufacturing facilities and expanding existing ones, supply bottlenecks for semaglutide are a persistent issue.