FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

发布时间： 2025-02-10 阅读：109次

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On February 5, 2025, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death. With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class. 

This FDA approval is based on results from the FLOW phase 3b kidney outcomes trial. FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing once-weekly Ozempic® 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR <15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, and CV death in adults with type 2 diabetes and CKD.