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Novo Nordisk (NVO+0.47%) announced today that its blockbuster drug Ozempic was approved by the Food and Drug Administration (FDA) as the first GLP-1 treatment for chronic kidney disease among people with type 2 diabetes.
The popular diabetes drug can now be used to reduce the risk of kidney disease worsening, kidney failure, and death due to heart disease in adults with type 2 diabetes and chronic kidney disease.
This is latest in a series of FDA-approved uses of GLP-1 drugs, which have become popular for weight loss as well as for conditions associated with diabetes, like sleep apnea.
“Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities,” said Anna Windle, a senior vice president at Novo Nordisk, in a press release.
The approval was based on a late-stage clinical trial, which found that a weekly, one-milligram injection of semaglutide, the active ingredient in Ozempic and the weigh- loss drug Wegovy, was found to reduce the combined risk of major kidney complications (including kidney failure), cardiovascular events, and even death from any cause by 24% in patients with type 2 diabetes and chronic kidney disease.
Novo Nordisk ended the trial early in 2023 after an independent monitoring committee determined that Ozempic’s efficacy in treating chronic kidney disease was clear. The trial followed 3,533 people with kidney disease and type 2 diabetes, half of whom took semaglutide while the other half was given a placebo, for more than three years.
Chronic kidney disease is a condition in which the kidney can’t filter blood properly. It affects more than 35.5 million U.S. adults, per the Centers for Disease Control and Prevention. About 40% of people with type 2 diabeetes also experience chronic kidney disease, according to Novo Nordisk.