FibroGen, Inc. and Astellas Pharma Inc. announced on Friday that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of chronic kidney (CKD) in adult patients not on dialysis.
This approval will be the second in Japan for roxadustat through the FibroGen and Astellas collaboration after the therapy was approved and launched for use in adult patients with anemia of KCD 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 the patients.”
This approval is premised 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 III conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to show hemoglobin maintenance (Hb) levels over time. Roxadustat was widely well-tolerated, and the safety profile was similar to that of darbepoetin alfa. The other two studies (one Phase 3 and one Phase 2) support the efficacy and safety of roxadustat in the 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.”