Astellas & FibroGen announced submission sNDA for Approval to Japan's Ministry of Health

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") announced the submission of a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare to gain marketing approval for Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients. Roxadustat was approved in Japan for the treatment of anemia associated with CKD in dialysis dependent (DD) patients in September 2019 and launched for use in this indication in November 2019.

The sNDA for the use of roxadustat in NDD-CKD patients is supported by three studies in more than 500 Japanese patients, which establish the profile within this group of patients.1,2,3 The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa (genetical recombination) ("darbepoetin alfa"), met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.1 Roxadustat was well tolerated and the safety profile of roxadustat was comparable to that of darbepoetin alfa.1 The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy in patients naïve to erythropoiesis-stimulating agents (ESAs).2,3

"The data demonstrates that roxadustat is effective in increasing and maintaining Hb levels within the target range in patients with anemia associated with CKD who are not on dialysis," said Bernhardt G Zeiher, M.D., Chief Medical Officer, Astellas. "This submission is an important next step to bringing roxadustat to even more patients with this condition in Japan, and this is particularly pertinent in the non-dialysis setting where many patients' anemia is currently not treated, or not treated to target."

"We are excited to reach another important milestone for roxadustat and appreciate the joint team's commitment to addressing the significant unmet medical need of patients living with anemia associated with CKD," said K Peony Yu, M.D., Chief Medical Officer, FibroGen.