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.
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD),
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.
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.
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.
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)
Semaglutide is now approved for reducing the risk for worsening kidney disease and cardiovascular death in adults with chronic kidney disease.
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,
The FDA has approved popular antiobesity drug Ozempic to help protect patients with type 2 diabetes from 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.
The US Food and Drug Administration (FDA) approval is based on the clinical trials that showed how Ozempic, the diabetes drug, showed a reduced risk of kidney failure. Experts explain how the drug helps.