FDA Approves Dapagliflozin to Treat Chronic Kidney Disease in Adults at Risk of Progression, Regardless of Diabetes Status

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The US Food and Drug Administration (FDA) has approved dapagliflozin (Farxiga^®, AstraZeneca) oral tablets for the treatment of chronic kidney disease (CKD) among adults with CKD who are at risk for disease progression, regardless of diabetes status.

More specifically, dapagliflozin—a sodium-glucose cotransporter 2 inhibitor—has been approved to reduce the risk of kidney function decline, kidney failure, cardiovascular (CV) death, and hospitalization for heart failure among patients with CKD, according to the April 30, 2021, FDA press release.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, MS, deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

The approval was based on results from the DAPA-CKD phase III trial. In this multicenter, double-blind study, 4304 patients with CKD stages 2-4, with and without diabetes, were randomly assigned to receive either dapagliflozin 10 mg or a placebo.

Researchers then compared the 2 groups for the number of patients whose disease progressed to a composite endpoint that included at least a 50% reduction in kidney function, progression to kidney failure, or CV or kidney death.

The results showed that 197 of the 2152 patients who received dapagliflozin had at least 1 of the composite endpoint events compared to 312 of the 2152 patients who received a placebo. Also, 100 patients in the dapagliflozin group were hospitalized or died compared to 138 patients in the placebo group.

“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status. This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease,” said Hiddo L. Heerspink, PhD, lead author of the DAPA-CKD trial, in an AstraZeneca press release.

Dapagliflozin was not studied, nor is it expected to be effective, in treating CKD among patients with autosomal dominant or recessive polycystic kidney disease or patients who require or have recently used immunosuppressive therapy for kidney disease, noted the FDA press release.

Dapagliflozin was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes (T2D) in addition to diet and exercise. It has since been granted indications to reduce the risk of hospitalization for heart failure (hHF) in adults with T2D and established CV disease or multiple CV risk factors and to reduce the risk of CV death and hHF in adults with heart failure (NYHA class II-IV) with reduced ejection fraction with and without T2D.