FDA Approves Ozempic Indications for Reducing Risk of Kidney Failure, Cardiovascular Death

The glucagon-like peptide-1 receptor agonist (GLP-1 RA) Ozempic (semaglutide) has been approved by FDA for the reduction of risk of kidney disease worsening, kidney failure or end-stage kidney disease, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD), according to a press release from the drug’s maker Novo Nordisk on Jan. 28, 2025 (1).

"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. 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," said Anna Windle, PhD, senior vice president Clinical Development, Medical & Regulatory Affairs at Novo Nordisk, in the release (1). "With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class."

The approval was based on results from a Phase IIIb trial (FLOW) that investigated the effects of the once-daily semaglutide injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD (1).

"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard E. Pratley, MD, medical director at the AdventHealth Diabetes Institute Orlando, Fl., and co-chair of the FLOW trial. "Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option."

FDA first approved Ozempic in 2017 to improve blood sugar, along with diet and exercise, in adults with type 2 diabetes (1). In June 2024, Ozempic’s increasing popularity as a weight loss prescription, due to semaglutides’ tendency to suppress appetite, led the World Health Organization to issue a medical product alert for three falsified batches (2).

Pharmaceutical Technology^®’s January 27 edition of Behind the Headlines made mention of Ozempic alongside numerous other medications that encompass a large percentage of overall drug expenditure in the latest round of Medicare price negotiations (3).

This latest FDA approval for Ozempic follows the agency’s December 2024 approval of Hikma Pharmaceuticals’ liraglutide injection, making it the first generic version of Novo Nordisk’s Victoza (liraglutide injection), a GLP-1 receptor agonist, indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes, as an adjunct to diet and exercise (4).

References

1. Novo Nordisk. FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease. Press Release. Jan. 28, 2025.
2. WHO. WHO Issues Warning on Falsified Medicines Used for Diabetes Treatment and Weight Loss. Press Release. June 20, 2024.
3. Spivey, C. Behind the Headlines: Sana’s Type 1 Diabetes Breakthrough, Drug Price Negotiations, and More. PharmTech.com, Jan. 27, 2025.
4. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.