In an important regulatory win for Denmark’s Novo Nordisk (NOV: N), the US Food and Drug Administration (FDA) yesterday 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).
The company noted that this approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic injection 0.5mg, 1mg, or 2mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. The European regulator approved Ozempic for the same use in December.
In patients who took Ozempic, kidney function declined more slowly, the risk of major cardiovascular events such as heart attack dropped 18% and the risk of death from any cause fell 20% compared with the placebo. Ozempic also cut the risk of cardiovascular-related deaths by 29%.
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