FDA Approves Farxiga® for Treatment of CKD

In a press release on April 30, 2021, the US FDA announced the approval of Farxiga® (dapagliflozin) oral tablets for the treatment of adults with chronic kidney disease (CKD) who are at risk of disease progression. Dapagliflozin has been shown to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in that patient population.

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

Farxiga was not studied, nor is expected to be effective, in treating CKD in patients with autosomal dominant or recessive polycystic kidney disease or among patients who require or have recently used immunosuppressive therapy to treat CKD. Patients who have a history of serious hypersensitivity reactions to the medication or those who are on dialysis therapy should not use Farxiga according to the press release.

Farxiga was initially approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise. The drug received Fast track, Breakthrough Therapy, and Priority Review designations for the treatment of CKD. The approval was granted to AstraZeneca.