Chronic kidney disease (CKD) is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD. For people with type 2 diabetes, CKD can be a significant burden and may lead to further complications, including increased risk of cardiovascular complications and death.

      The FDA had now approved Ozempic® to lower the risk of kidney failure, worsening kidney disease, and cardiovascular disease-related death. The approval by FDA is based on the findings from the pivotal FLOW phase 3b kidney outcomes trial which investigated the effects of once-weekly Ozempic® injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD. 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. 3,533 adults (1,767 in the Ozempic® group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at approximately 400 investigator sites.

      The FLOW trial achieved its primary endpoint with Ozempic® 1 mg, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared to placebo, when added to standard of care.

      Ozempic's current indications for individuals with type 2 diabetes are expanded by its approval to enhance glycaemic management and to reduce the risk for major cardiovascular events in adults who also have known heart disease.