It will be given to adults with chronic kidney disease (CKD) at risk of progression to reduce the risk of decline of the condition to the stage where kidneys can’t function on their own, cardiovascular death and hospitalisation for heart failure.
The decision was based on results from a late-stage trial and follows the priority review designation granted 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.
It is expected to become the fifth leading cause of mortality globally by 2040.
Currently in the US, 37mln people are estimated to have CKD.
“Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D.
“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.”