FDA Approves New Indication for Semaglutide (Ozempic) to Lower Kidney Risks in Type 2 Diabetes, CKD

The US FDA approved semaglutide (Ozempic, Novo Nordisk) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).¹

This newest approval in CKD establishes semaglutide injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class, according to a January 28, 2025, press release from Novo Nordisk.¹

The FDA’s decision was based on results from the FLOW clinical trial, a phase 3b, international, placebo-controlled study evaluating the effect of once-weekly injectable semaglutide 1.0 mg against placebo as an adjunct to standard of care on kidney outcomes in a cohort of 3533 individuals with T2D or CKD. The trial was stopped early after 3.4 years of follow-up due to meeting pre-specified efficacy criteria.¹

The study achieved its primary endpoint with semaglutide, demonstrating a 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease (CVD) compared with placebo when added to standard of care.²

"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," Richard Pratley, MD, medical director at the AdventHealth Diabetes Institute Orlando, and co-chair of the FLOW Trial, said in a press release.¹

Pratley continued: "A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients."¹

Initially approved in 2017 to improve blood sugar, along with diet and exercise, in adults with T2D, semaglutide was granted an additional indication in 2020 to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with T2D with known CVD.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," Anna Windle, PhD, Senior Vice President Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said in the release.¹

References:

1. 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. News release. Novo Nordisk. January 28, 2025. Accessed January 28, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915253

2. Jennings S. FLOW trial: Semaglutide lowers risk for major kidney disease, CV events and death regardless of SGLT-2i use. Patient Care Online. June 25, 2024. https://www.patientcareonline.com/view/flow-trial-semaglutide-lowers-risk-for-major-kidney-disease-cv-events-and-death-regardless-of-sglt-2i-use