Astellas Pharma: Roxadustat Approved In Japan For Adults With Anemia Of CKD Not On Dialysis

(RTTNews) - Astellas Pharma Inc. (ALPMY) and FibroGen, Inc. (FGEN) announced that Japan's Ministry of Health, Labour and Welfare approved EVRENZO (roxadustat) for the treatment of anemia of chronic kidney disease in adult patients not on dialysis. This approval triggers a milestone payment of $15 million by Astellas to FibroGen.

The approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. The phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint. Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa.