Astellas Pharma Inc. (TSE:4503, “Astellas”) and FibroGen, Inc. (“FibroGen”), announced the dosing of the first patient in Phase 3 trials in Japan of roxadustat (development code: ASP1517/FG-4592) for treatment of anemia in chronic kidney disease (CKD), which triggered a $10 million milestone payment from Astellas to FibroGen.
The initiation of Phase 3 studies in Japan follows the positive results from two Phase 2 studies in Japan of roxadustat in CKD patients on dialysis and in CKD patients not on dialysis. In the Phase 2 studies in Japan of CKD patients receiving dialysis and not receiving dialysis, roxadustat was well tolerated and met the primary objective of demonstrating dose-related rates of hemoglobin (Hb) increase measured over the first six weeks of treatment, as well as anemia correction and Hb maintenance over the 24-week treatment period.
“Anemia is a common consequence of CKD and contributes to the poor quality of life associated with this disease,” said Dr. Bernie Zeiher, President, Development of Astellas. “We are pleased to advance roxadustat to Phase 3 studies in Japan, as a potential new oral treatment of anemia in CKD patients.” “We are encouraged by accumulated results showing roxadustat’s potential to be effective in treating anemia and well tolerated in Phase 2 clinical studies around the globe in multiple types of CKD patients with anemia. We appreciate the strong support from patients and physicians with respect to the roxadustat clinical development program, and believe roxadustat has the potential to improve the care of CKD patients with anemia,” said Thomas B. Neff, Chief Executive Officer of FibroGen.