Novo Nordisk eyes another Ozempic approval by January

By January 2025, Type 2 diabetes therapy Ozempic might be FDA approved for kidney disease-related events. 

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. 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars