The FDA has approved popular antiobesity drug Ozempic to help protect patients with type 2 diabetes from kidney disease.
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.
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.
Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes.
The US Food and Drug Administration on Tuesday approved Ozempic for adults with type 2 diabetes and chronic kidney disease (CKD). The drug is now indicated specifically to treat kidney failure, prevent death from cardiovascular disease,
Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, Novo Nordisk said.
It showed that 1 mg Ozempic led to a 24 per cent reduced risk of worsening kidney disease and kidney failure (end-stage kidney disease)
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.
Ozempic’s expanded approval in the U.S. could transform how doctors treat patients with the condition, which involves a gradual loss of kidney function.
Semaglutide is now approved for reducing the risk for worsening kidney disease and cardiovascular death in adults with chronic kidney disease.
The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals, NBC News reported.