FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

Richard Pratley, MD

Credit: International Geriatric Diabetes Society

The US Food and Drug Administration has approved semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).¹

According to a January 28, 2025, press release from Novo Nordisk, the decision is based on results from the phase 3b FLOW kidney outcomes trial demonstrating semaglutide’s statistically significant and superior 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease compared with placebo when added to standard of care.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," Richard Pratley, MD, medical director at the AdventHealth Diabetes Institute Orlando, and co-chair of the FLOW Trial, said in a press release.¹ "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."

Initially approved in 2017 to improve blood sugar, along with diet and exercise, in adults with type 2 diabetes, 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 type 2 diabetes with known heart disease. According to Novo Nordisk, its 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.¹

An international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial, FLOW compared once-weekly semaglutide 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%; sustained eGFR < 15 mL/min/1.73 m2; chronic renal replacement therapy; renal death; and CV death in adults with type 2 diabetes and CKD. The trial, which was initiated in 2019, enrolled 3533 adults at approximately 400 investigator sites and was stopped early at the recommendation from an Independent Data Monitoring Committee due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.¹

Results showed use of semaglutide was associated with a 24% relative risk reduction for the trial’s primary outcome of major kidney disease events compared to placebo therapy (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88; P = .0003). Additional analysis leveraging kidney-specific components of the primary outcome suggested semaglutide use was associated with a 21% reduction in risk relative to placebo therapy (HR, 0.79; 95% CI, 0.66 to 0.94). Furthermore, analysis of death from cardiovascular causes revealed a 29% relative risk reduction versus placebo therapy (HR, 0.71; 95% CI, 0.56 to 0.89).²

"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 and Regulatory Affairs at Novo Nordisk.¹ "With this new indication, Ozempic® stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk's commitment to cardiometabolic care."

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. January 28, 2025. Accessed January 28, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915253}
2. ^{Campbell P. FLOW Trial Fortifies Semaglutide's Role in Chronic Kidney Disease and Type 2 Diabetes. HCPLive. May 24, 2024. Accessed January 28, 2025. https://www.hcplive.com/view/flow-trial-fortifies-semaglutide-s-role-in-chronic-kidney-disease-and-type-2-diabetes}