Additional Ozempic Indication Approved

FDA has approved a new indication for Novo Nordisk’s Ozempic (semaglutide), which the company says makes it the only GLP-1 receptor agonist to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 diabetes and chronic kidney disease. The company says the approval was based on results from the pivotal Phase 3b FLOW kidney outcomes trial.

Novo says FLOW achieved its primary endpoint with Ozempic 1 mg demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease compared to placebo when added to standard of care.

FDA first approved Ozempic in 2017 with diet and exercise to improve glucose in adults with Type 2 diabetes. It received an additional indication in 2020 to reduce the risk of major cardiovascular events in adults with Type 2 diabetes.