FDA Approves Ozempic for Reducing Kidney Disease Risks in Adults with Type 2 Diabetes and Chronic Kidney Disease

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Ozempic (semaglutide) 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)13.

Clinical Trial:
The approval is based on the FLOW phase 3b kidney outcomes trial, which demonstrated a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure, and death due to cardiovascular disease compared to placebo12.

Expanded Indication:
This new indication establishes Ozempic as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class, addressing conditions within the cardiovascular-kidney-metabolic syndrome1.

Prevalence of CKD:
Approximately 37 million adults in the U.S. are affected by CKD, with diabetes being a leading cause. About 40% of people with type 2 diabetes also experience CKD13.

Impact:
The approval offers a new treatment option for millions of adults living with both type 2 diabetes and CKD, providing hope for more holistic approaches to managing these conditions3.

Additional Benefits:
The FLOW trial also showed reductions in the risk of major cardiovascular events (18%) and all-cause mortality (20%) among participants taking Ozempic23.

Sources:

1. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915253

2. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=915077

3. https://evrimagaci.org/tpg/fda-approves-ozempic-for-chronic-kidney-disease-treatment-165940