AstraZeneca's Forxiga gets US approval for chronic kidney disease
AstraZeneca said on Tuesday that Farxiga has been approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes.
The pharmaceuticals giant said the approval by the US Food and Drug Administration is "the most significant advancement in the treatment of chronic kidney disease in more than 20 years".
The approval was based on positive results from the DAPA-CKD Phase III trial and the decision follows the Priority Review designation granted by the FDA earlier this year.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said: "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."