TOKYO and San Francisco, October 1, 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 Astellas submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat (generic name, development code: ASP1517/FG-4592) for the treatment of anemia associated with Chronic Kidney Disease (CKD) in patients on dialysis. The results obtained from four Phase 3 studies conducted in CKD patients on dialysis in Japan support this NDA submission.
“We are pleased to report the submission of the Japan NDA for roxadustat as a treatment of anemia associated with CKD in patients on dialysis,” said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. “We believe roxadustat offers a potential new oral therapeutic option for a condition which can have a debilitating impact on patients with renal disease.”
“We are excited about this critical advancement as we work together to bring this new therapy to patients with anemia associated with CKD in Japan,” said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. “We appreciate the joint team’s dedicated effort and commitment to addressing important unmet medical needs of these patients and their physicians.”
Anemia is a common complication of CKD and is associated with significant morbidity and mortality in dialysis and non-dialysis populations. Anemia is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin (Hb), a protein in red blood cells that carries oxygen to cells throughout the body. Anemia is associated with increased risk of hospitalization, cardiovascular complications, need for blood transfusion, exacerbation of other serious medical conditions, and death. In addition, anemia frequently causes significant fatigue, cognitive dysfunction, and decreased quality of life. The more severe the anemia, as measured by lower Hb levels, the greater the health impact on patients. Treatment for anemia in CKD patients is a critical worldwide healthcare issue that represents a large and growing unmet medical need.