A nine-month supply of Novo Nordisk's diabetes drug Ozempic in a refrigerator in London on Oct. 20, 2023. (Handout via Reuters)
The Food and Drug Administration (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), the Danish drugmaker said on Tuesday.
Novo's blockbuster diabetes drug Ozempic belongs to a class of drugs known as GLP-1 receptor agonists and has the same active ingredient as its popular obesity treatment Wegovy.
The FDA's approval makes the drug, chemically known as semaglutide, to become the first GLP-1 treatment option for people with type 2 diabetes and CKD.
"Such an approval adds to the mounting body of evidence showing GLP-1 agents' utility in indications beyond type 2 diabetes and obesity," BMO Capital analyst Evan Seigerman said.
The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney disease and major cardiac events by 24 percent, the company said.
Ozempic is also approved to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with diabetes and known heart disease.
Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the label of Ozempic.
Novo Nordisk estimates that around 40 percent of people with type 2 diabetes have chronic kidney disease, which affects about 37 million adults in the United States.
Last year, the FDA had approved the use of Wegovy for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
Novo Nordisk is also testing its GLP-1 treatments for benefits beyond diabetes and weight-loss, including Alzheimer's disease and a common type of fatty liver disease known as non-alcoholic steatohepatitis (NASH).