Dapagliflozin receives FDA fast track designation for chronic kidney disease

AstraZeneca’s dapagliflozin (FARXIGA) has received FDA's Fast Track designation for chronic kidney disease (CKD). Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor designed for improving and managing blood sugar control in type 2 diabetes patients.

This will accelerate the development and review of the therapy compared to standard FDA procedure. The drug is indicated to delay the progression of renal failure and prevent renal and cardiovascular death in chronic kidney disease patients with and without type 2 diabetes.

“Chronic kidney disease affects an estimated 37 million people in the US and is often associated with an increased risk of heart disease and stroke. This Fast Track designation is an important step towards 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," Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said in a press release.

The drug is currently being assessed in the Phase III DAPA-CKD clinical trial. The trial evaluates the effect of FARXIGA on renal outcomes and CV mortality in patients with CKD with and without T2D versus placebo, on top of standard of care.

CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate (eGFR), markers of kidney damage, or both, for at least three months. The most common causes of CKD are diabetes and hypertension. CKD affects an estimated 37 million adults in the US.

CKD is associated with increased risk of therapy-resistant hypertension, chronic fluid overload, heart failure, and CV and all-cause death. In its most severe form, known as end-stage renal disease (ESRD), kidney damage and deterioration of kidney function have progressed to the stage where dialysis or kidney transplantation are required. More than half of all deaths among patients with ESRD are from CV causes.

FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.