Astellas Submits New Drug Application in Japan of Roxadustat for The Treatment of Anemia Associated with Chronic Kidney Disease in Patients on Dialysis

TOKYO and SAN FRANCISCO, Oct. 01, 2018 (GLOBE NEWSWIRE) — 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.

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