Farxiga for the treatment of chronic kidney disease approved by FDA

News

Аvera Allen, Deputy Editor In Chief

Date: 17.05.2021

AstraZeneca’s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression.

The approval by the Food and Drug Administration (FDA) was based on positive results from the DAPA-CKD Phase III trial. The decision follows the Priority Review designation granted by the FDA earlier this year.

CKD, a condition defined by decreased kidney function, is often associated with a heightened risk of heart disease or stroke, or the need for dialysis or kidney transplant.1-3 CKD is expected to become the fifth leading cause of mortality globally by 2040.4 Currently in the US, 37 million people are estimated to have CKD.

In the US, Farxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D), and to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors. Farxiga is also indicated to reduce the risk of CV death and hHF in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.

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