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.
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)
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 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,
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 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.
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.
Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the risk of heart attacks and strokes.
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks associated with chronic kidney disease (CKD).
The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals, NBC News reported.