FDA fast-tracks dapagliflozin for treatment of CKD

The U.S. FDA this month granted Fast Track designation to AstraZeneca for the development of Farxiga, or dapagliflozin. 

According to a statement from AstraZeneca, Farxiga was designed to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease (CKD). The FDA’s designation is for CKD patients with and without type 2 diabetes.

“Chronic kidney disease affects an estimated 37 million people in the U.S., and is often associated with an increased risk of heart disease and stroke,” Mene Pangalos, executive VP and BioPharmaceuticals R&D at AstraZeneca, said in the statement. “This Fast Track designation is an important step toward more quickly addressing unmet treatment needs in chronic kidney disease, and we will work closely with the FDA to explore the potential for Farxiga to improve outcomes for these patients.”

Right now, Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in type 2 diabetics, but it’s not recommended for people with type 1 diabetes or diabetic ketoacidosis. Contraindications include prior serious hypersensitivity to dapagliflozin, severe renal impairment and end-stage renal disease.

AstraZeneca said the Phase III DAPA-CKD clinical trial is currently in progress and will evaluate the effect of Farxiga plus standard care on renal outcomes and CV mortality in patients with CKD and with and without type 2 diabetes.