FGEN - Astellas Pharma and FibroGen's roxadustat Ok'd in Japan for renal anemia

Japan's Ministry of Health, Labor and Welfare has approved Astellas Pharma (ALPMF) and FibroGen's (FGEN) EVRENZO (roxadustat) for the treatment of anemia in non-dialysis-dependent adults with stage 3-5 chronic kidney disease.The approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. Previously, the company announced positive results from a Phase 3 clinical trial, DOLOMITES, evaluating roxadustat for the treatment of anemia in non-dialysis-dependent adults with stage 3-5 chronic kidney disease.  Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa. The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy of roxadustat in erythropoiesis-stimulating agent ((ESA))-untreated patients.The approval of the supplementary New Drug Application (sNDA) for roxadustat triggers a milestone payment of $15M by Astellas to FibroGen. Previously, approval in Japan was received for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched

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Astellas Pharma and FibroGen's roxadustat Ok'd in Japan for renal anemia