Astellas Pharma Inc. and FibroGen, Inc. today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

"We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows even more patients to access this important new treatment option," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. "With its novel mechanism of action and oral administration, we hope roxadustat will alleviate some of the burden associated with anemia of CKD prior to the initiation of dialysis and deliver meaningful improvements in the lives of these patients."

This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time. 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.

"Today's approval is another milestone achievement for both FibroGen and Astellas," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. "By bringing roxadustat to adult patients living with anemia of CKD, both on dialysis and not on dialysis, we are continuing our efforts to meet the significant unmet medical need of patients in this community."

The approval of the supplementary New Drug Application (sNDA) for roxadustat in Japan for the treatment of anemia of CKD in adult patients not on dialysis triggers a milestone payment of $15 million by Astellas to FibroGen.

As a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat increases Hb levels through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates the body's natural protective response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia.