The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic for reducing the risk of kidney failure, disease progression, and heart-related fatalities in diabetes patients with chronic kidney disease (CKD), Danish pharmaceutical company.
Ozempic, a widely used diabetes medication, falls under the class of GLP-1 receptor agonists and contains the same active ingredient, semaglutide, as Novo Nordisk’s popular obesity treatment, Wegovy. With this approval, Ozempic becomes the first GLP-1 therapy authorized for use in individuals with type 2 diabetes and CKD.
BMO Capital analyst Evan Seigerman noted that this approval further highlights the expanding therapeutic potential of GLP-1 agents beyond their traditional use in type 2 diabetes and obesity.
The FDA’s decision was supported by data from a late-stage clinical study demonstrating that Ozempic reduced the risk of death from chronic kidney disease and major cardiovascular events by 24%, Novo Nordisk stated.
In addition to this latest approval, Ozempic is already authorized to lower the risk of major cardiovascular events such as heart attack, stroke, or death in adults with diabetes and pre-existing heart disease.
Regulatory bodies outside the U.S. have also recognized Ozempic’s benefits. Last month, the European Medicines Agency (EMA) permitted Novo Nordisk to update Ozempic’s label to include its role in reducing risks associated with kidney disease.
Chronic kidney disease affects approximately 37 million adults in the United States, and Novo Nordisk estimates that around 40% of individuals with type 2 diabetes also have CKD.
This development follows last year’s FDA approval of Wegovy for reducing the risk of stroke and heart attack in overweight or obese adults who do not have diabetes. Novo Nordisk continues to explore additional applications for its GLP-1 treatments, including potential benefits for Alzheimer’s disease and non-alcoholic steatohepatitis (NASH), a prevalent form of fatty liver disease.
This approval marks a significant milestone in expanding treatment options for patients managing diabetes and chronic kidney disease, reinforcing the growing role of GLP-1 therapies in broader health applications.
