Novel Drug & Emergent Therapeutics | Pharmaceuticals Nephrology
FDA Approves Ozempic® as First GLP-1 RA to Reduce Kidney Disease Progression & Mortality in Type 2 Diabetes
Time to read: 00:56
Originally published: 28 January 2025
Source: PRNewswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN003
Category: Nephrology
Crossreference: Diabetes, Gerontology
Keyword: CKD, T2D, diabetes, renal failure, GLP-agonist, Oxempic
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The U.S. Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular-related death in adults with type 2 diabetes and chronic kidney disease (CKD).
This expands its previous approvals for improving glycaemic control and reducing major cardiovascular events in adults with type 2 diabetes and heart disease, making it the most broadly indicated GLP-1 receptor agonist (GLP-1 RA) in its class.
Around 40% of people with type 2 diabetes also have CKD, increasing their risk of severe complications, including cardiovascular disease and mortality.
Addressing this critical need, the FDA approval is based on results from the FLOW phase 3b trial. The trial demonstrated a 24% relative risk reduction (4.9% absolute risk reduction at three years) in kidney disease worsening, kidney failure, and cardiovascular-related death with once-weekly Ozempic® 1 mg, compared to placebo.
Experts emphasize the impact of this approval, noting that patients with type 2 diabetes and CKD require medications that provide both kidney and cardiovascular protection. Since its initial approval in 2017 for blood sugar control, followed by a 2020 indication for reducing cardiovascular events, Ozempic® has continued to expand its role in managing cardiometabolic conditions.
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