FDA approves dapagliflozin (farxiga) for chronic kidney disease

May 1, 2021 0 By FM

The US Food and Drug Administration (FDA) has approved the drug Dapagliflozin for adult patients with chronic kidney disease (CKD) at the risk of disease progression. The drug marketed by AstraZeneca as Farxiga is expected to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with CKD.

Dapagliflozin was first approved in 2014 to improve glycemic control in patients with diabetes mellitus. Then the approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction. The latter was based on the results of the DAPA-HF trial. The current approval comes from the results of the DAPA-CKD trial that was stopped early in March 2020 due to the efficacy shown by the drug towards CKD.

The trial included 4304 patients with CKD randomly selected but without diabetes. They were split into two groups, one receiving Dapagliflozin and the other a placebo. During a span of 2.4 years, treatment with Dapagliflozin led to a significant 31% relative reduction compared with placebo. At least a 50% drop in the estimated glomerular filtration rate was observed. Dapagliflozin treatment also could reduce the mortality rate by 31%.

However, Dapagliflozin should not be used in patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis. Serious cases of Fournier’s Gangrene which are life-threatening occurred in patients with diabetes taking Dapagliflozin. Patients are advised to take a lower dose of insulin or to reduce hypoglycemic risk if they are taking Dapagliflozin.

Dapagliflozin is however not recommended for treating chronic kidney disease due to autosomal dominant or recessive polycystic kidney disease. It will not be effective in patients who require immunosuppressive therapy or recently received such a therapy used to treat kidney disease. The effectiveness of Dapagliflozin as reported first at the European Society of Cardiology Congress in 2020 is now published in the New England Journal of Medicine also.