Ozempic Approval Expanded to Include Patients with T2D and CKD: Daily Dose

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On January 28, 2025, we reported on the US FDA approval of semaglutide (Ozempic, Novo Nordisk) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The approval

This newest approval establishes Ozempic as the only glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for mitigating cardiovascular (CV) risks and kidney disease that has advanced—when added to standard care—in this patient population.

The FDA's decision was informed by the FLOW phase 3b clinical trial evaluating the effect of once-weekly injectable semaglutide 1.0 mg against placebo as an adjunct to standard of care on kidney outcomes in a cohort of 3533 individuals with T2D or CKD. The study achieved its primary endpoint with semaglutide, demonstrating a 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease compared with placebo when added to standard of care.

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