Novo Nordisk A/S’s blockbuster Ozempic won US approval to treat chronic kidney disease in patients who also have type 2 diabetes, further expanding the popular drug’s use.
Semaglutide is now approved for reducing the risk for worsening kidney disease and cardiovascular death in adults with 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,
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.
Novo Nordisk (NVO) said its popular diabetes drug Ozempic, or semaglutide, has been approved for the treatment of patients with chronic kidney disease and diabetes. Read more here.
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and strokes.
Expanded Ozempic approval in the U.S. could transform how doctors treat patients with chronic kidney disease, which involves a gradual loss of kidney function.
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
The Food and Drug Administration approved Ozempic to be used to lessen the risk of kidney disease from getting worse, end-stage kidney disease and cardiovascular disease-caused death for patients with type 2 diabetes and chronic kidney disease.
Novo Nordisk’s Ozempic (semaglutide) has been approved by the US Food and Drug Administration (FDA) to reduce the risk of kidney disease worsening, kidney failure and cardiovascular disease (CVD) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
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.