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).
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%, the company said, Reuters reported. With the US FDA nod, the drug, chemically known as semaglutide, became the first GLP-1 treatment option for people with type 2 diabetes and chronic kidney disease. 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.
“This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class,” the Danish drugmaker said.
“CKD affects approximately 37 million adults in the U.S. and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure. CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.2,4 For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death,” it added.
The US FDA initially approved Ozempic in 2017 to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes. In 2020, Ozempic was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.
Novo Nordisk is conducting a different study to understand how and why semgalutide seems to reduce the progression of kidney disease, Stephen Gough, global chief medical officer and senior vice president at Novo Nordisk told CNN.
