The FDA is expected to decide whether or not to approve FibroGen Inc.’s (FGEN) Roxadustat for the treatment of anemia of chronic kidney disease on December 20.Roxadustat is proposed for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. According to the United States Renal Data System, over 14% of the U.S. adult population is affected by CKD, and a majority of dialysis-eligible CKD patients are currently on dialysis. It is estimated that approximately 509,000 patients are receiving dialysis in the U.S. as of 2016.In clinical trials, Roxadustat was proven to be superior to placebo in correcting anemia in nondialysis CKD patients and was non-inferior to epoetin alfa for treatment of anemia in CKD patients receiving dialysis.FibroGen and its partner AstraZeneca are collaborating on the development and commercialization of Roxadustat in the U.S., China, and other markets.Roxadustat is already approved in China and Japan under the brand name Evrenzo for both nondialysis-dependent and dialysis-dependent kidney patients.According to EvaluatePharma, Roxadustat could bring in sales of $1.488 billion by 2024.FGEN closed Friday’s (Nov.27, 2020) trading at $40.17, up 0.37%.