TOKYO and San Francisco, May 31, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff, “FibroGen”) today announced that the fourth Japan Phase 3 study for roxadustat met its primary endpoint. This study evaluated the efficacy and safety of roxadustat compared to darbepoetin alfa (genetical recombination) (“darbepoetin alfa”) in hemodialysis-dependent chronic kidney disease (CKD) patients with anemia and previously treated with recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
“We are encouraged by these positive data from our Phase 3 key study in Japan, and are pleased with our overall development progress to date in the region,” said Salim Mujais, M.D., senior vice president and global therapeutic area head, Medical Specialties Development, Astellas. “We look forward to continuing to advance the development of roxadustat to hopefully provide the value of a new therapeutic option to patients suffering from CKD with anemia.”
“The positive topline results from this latest Japan Phase 3 study are consistent with previously reported results from roxadustat Phase 3 studies in Japan and in China, and from our extensive Phase 2 program,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “We are pleased with the growing body of clinical evidence showing roxadustat to be well tolerated and efficacious in treating anemia in CKD patients, including patients on hemodialysis and those on peritoneal dialysis in various regions worldwide.”
In the study, average hemoglobin (Hb) levels were effectively maintained at 10.99 g/dL at Weeks 18 to 24 in roxadustat-treated hemodialysis patients previously treated with erythropoiesis-stimulating agents (ESAs). The primary efficacy endpoint of change in average Hb levels from baseline to Weeks 18 to 24 was -0.04 g/dL and -0.03 g/dL in the roxadustat-treated group and in the darbepoetin-treated group, respectively. The non-inferiority of roxadustat to darbepoetin alfa in change of average Hb from baseline was confirmed as the lower bound of the 95% confidence interval (-0.18, 0.15) of the treatment difference was greater than the pre-specified non-inferiority margin (-0.75 g/dL).
Roxadustat was well tolerated in this study, and the safety profile of roxadustat was consistent with that observed in previous studies both in dialysis and non-dialysis patients.
Further detailed data from this study are expected to be reported in the future.
Astellas is a sponsor of a total of six Phase 3 studies of roxadustat in Japan for anemia associated with CKD in both dialysis and non-dialysis patients. This study is the final Phase 3 study in Japan evaluating roxadustat for the treatment of anemia in CKD patients on dialysis. Astellas is planning the submission of the new drug application in Japan for this indication later this year. The two Japan Phase 3 studies in non-dialysis patients are ongoing.