The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks associated with chronic kidney disease (CKD).
Approval was based on results from the Phase IIIb FLOW trial, which demonstrated a 24% relative risk reduction in kidney disease, kidney failure, and cardiovascular death in patients treated with Ozempic.
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and strokes.
The FDA’s approval of Ozempic to battle chronic kidney disease “allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of
When Novo Nordisk unveiled kidney outcomes data for its star GLP-1 medicine Ozempic last May, the company’s executive medical director suggested the results could help set a new standard for “holis | The FDA on Tuesday gave Ozempic a thumbs-up to reduce the risk of kidney disease worsening,
The Food and Drug Administration approved Novo Nordisk’s Ozempic as the first GLP-1 treatment option for people with type 2 diabetes and chronic kidney disease.
Ozempic belongs to a class of drugs known as GLP-1 receptor agonists and has the same active ingredient as the company's popular obesity drug Wegovy. The U.S. Food and Drug Administration's approval was based on data from a late-stage study,
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The approval is based on results from the Phase III FLOW trial demonstrating Ozempic reduced the risk of severe kidney outcomes by 24% compared to placebo, including kidney failure, reduction in kidney function, or death from kidney or heart causes, in diabetic patients with chronic kidney disease.