Novo Nordisk’s Ozempic (semaglutide) has been approved by the US Food and Drug Administration (FDA) to reduce the risk of kidney disease worsening, kidney failure and cardiovascular disease (CVD) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
The decision makes Ozempic the only glucagon-like peptide-1 (GLP-1) receptor agonist approved for this patient population and the “most broadly indicated” drug in its class, according to Novo.
Ozempic was first approved by the FDA in 2017 to improve glycaemic control in adults with T2D, before being granted expanded approval in 2020 to reduce the risk of major cardiovascular events in adults with T2D and known heart disease.
The FDA’s latest decision on the drug was supported by positive results from the phase 3b FLOW trial, which evaluated a once-weekly 1mg injection of Ozempic on top of standard of care in adults with T2D and CKD.
The study met its primary endpoint, with Ozempic demonstrating a 24% relative risk reduction of kidney disease worsening, kidney failure and death due to CVD compared to placebo.
Approximately 37 million adults in the US are living with CKD, a progressive condition caused by decreased kidney function. The disease is a common complication of T2D, affecting about 40% of T2D patients.
Anna Windle, senior vice president clinical development, medical and regulatory affairs at Novo, said: “CKD is very serious and common in patients living with T2D and represents a critical need for adults living with these comorbidities.
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated.”
The approval comes just one week after Novo shared positive headline results from a late-stage study evaluating a higher dose of semaglutide in adults with obesity.
Among patients who adhered to treatment in the phase 3b STEP UP trial, those receiving the experimental 7.2mg dose of semaglutide achieved a superior weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with the standard 2.4mg dose, approved under the brand name Wegovy.