Novo Nordisk, the manufacturer of the popular medication, said June 24 the FDA has agreed to review a label extension based on positive phase 3 trial results. The study tested if Ozempic could reduce major kidney disease events among patients with diabetes and chronic kidney disease.
In late May, the Denmark-based drugmaker published the study findings: Ozempic cut the risk of kidney disease-related events by 24%, the risk of a major heart problem by 18% and the risk of death by 20%.
Michael Radin, MD, Novo Nordisk’s executive medical director of diabetes, told Becker’s the study was the “first ever renal outcomes trial with a GLP-1 receptor agonist” at the time.
As of June 25, most GLP-1 medications are solely approved for Type 2 diabetes or chronic weight management. Novo Nordisk’s Wegovy, a weight loss drug, is also indicated for serious heart problems, and Eli Lilly is seeking a sleep apnea approval for Mounjaro, its diabetes drug.
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