The FDA has approved semaglutide (Ozempic) as the sole glucagon-like peptide-1 receptor agonist (GLP-1 RA) for addressing cardiovascular and kidney risks in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). This approval broadens its use beyond its previous indication for T2D alone, now targeting patients with both conditions to mitigate risks of heart disease, stroke, and kidney failure. The drug has shown significant benefits in reducing adverse kidney outcomes and cardiovascular-related death risks through the FLOW trial, which demonstrated a nearly 5% risk decrease for CVD-related death at three years compared to placebo.
Semaglutide was first approved in 2017 for T2D and expanded in 2020 to include patients with heart disease. With CKD now included, it targets millions of adults facing both diabetes and kidney complications, a growing challenge as the aging population increases diabetes rates and its comorbidities. Richard E. Pratley, MD, highlighted the importance of this approval for his patients struggling with serious kidney issues.
The FLOW phase 3b trial confirmed semaglutide’s efficacy in reducing eGFR by at least 50% and lowering risk of CV or renal death, offering hope to millions with T2D and CKD. This marks semaglutide as a uniquely broad indication among GLP-1 RAs, underscoring Novo Nordisk’s commitment to advancing cardiometabolic care.
Sources:
1. FDA approves Ozempic 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. PR Newswire. January 28, 2025. Accessed January 28, 2025.
2. Diabetes and chronic kidney disease. National Kidney Foundation. Updated January 2016. Accessed January 28, 2025.
Source: https://www.ajmc.com/view/fda-expands-semaglutide-use-for-cv-kidney-risks-in-t2d-ckd