FDA Expands Semaglutide Use for CV, Kidney Risks in T2D, CKD

Today the FDA announced that it had expanded semaglutide’s (Ozempic; Novo Nordisk) indications to include patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The move means the drug is the sole glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for mitigating cardiovascular (CV) risks and kidney disease that has advanced—when added to standard care—in this patient population. This decision was informed by the FLOW (NCT03819153) phase 3b kidney outcomes trial, which found a correlation between once-weekly injections of semaglutide and a subsequently reduced risk of both cardiovascular disease (CVD) and adverse kidney outcomes.¹ 

For the FLOW trial, those in the treatment group exhibited a statistically significant 24% risk decrease for multiple adverse kidney outcomes, including progressive and end-stage kidney disease, as well as a nearly 5% risk decrease for CVD-related death at 3 years compared with the placebo group. | image credit: cartoon - stock.adobe.com

“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, Clincal Development, Medicat & Regulatory Affairs, Novo Nordisk, said in a statement.

Semaglutide received its first FDA approval back in 2017; at the time, it was only indicated for T2D to improve patients’ glucose and was recommended alongside exercise and dietary modifications. By 2020, semaglutide’s indication was expanded to include patients with T2D and forms of heart disease to mitigate their risks for stroke, heart attack, other CV episodes, or death.

CKD poses an additional risk for patients with T2D, occurring in around 40% of this population, and can influence the likelihood of developing CV issues and individual mortality risks. Diabetes itself remains a primary driver of CKD. As the aging population is expected to grow, data project a rising incidence of diabetes that could, in turn, result in a greater rates of kidney failure and CKD.²

"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,” Richard E. Pratley, MD, medical director, AdventHealth Diabetes Institute located in Orlando, Florida, noted in a statement.¹

The FLOW phase 3b kidney outcomes trial compared the efficacy of semaglutide 1 mg with a placebo, with one of the primary outcomes of interest being achieving and sustaining at least a 50% reduction in estimated glomerular filtration rate (eGFR), as well as an eGFR less than 15 mL/min/1.73 m². Outcomes related to CV or renal death, as well as chronic renal replacement therapy, were additional primary end points. The study population comprised 1767 adults with T2D and CKD in the semaglutide group and 1766 adults with T2D and CKD in the placebo group. Patients were featured from 28 countries, with the trial being conducted across an estimated 400 sites.

Those in the treatment group exhibited a statistically significant (P < .05) 24% risk decrease for multiple adverse kidney outcomes, including progressive and end-stage kidney disease, as well as a nearly 5% risk decrease for CVD-related death at 3 years compared with the placebo group.

“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," Wilde commented.

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. PR Newswire. January 28, 2025. Accessed January 28, 2025. https://www.prnewswire.com/news-releases/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-302362466.html

2. Diabetes and chronic kidney disease. National Kidney Foundation. Updated January 2016. Accessed January 28, 2025. https://www.kidney.org/diabetes-and-chronic-kidney-disease