Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Tuesday that Farxiga (dapagliflozin) has been approved in the United States for the treatment of chronic kidney disease (CKD) in patients at risk of progression with and without type-2 diabetes.
The US Food and Drug Administration (FDA) approved Farxiga, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, 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 CKD at risk of progression.
This decision follows the Priority Review designation granted by the FDA earlier this year and was based on positive results from a Phase III trial.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, described the FDA's approval of Farxiga as "the most significant advancement in the treatment of chronic kidney disease in more than 20 years".
He added: "We've shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US."
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