20.09.2019 09:19:48
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Astellas Pharma, FibroGen Announce Approval Of Evrenzo In Japan - Quick Facts
(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) and FibroGen, Inc. (FGEN) reported the approval of Evrenzo (generic name: roxadustat) in Japan for the treatment of anemia associated with chronic kidney disease in dialysis patients. This is the first approval for roxadustat through the Astellas and FibroGen association.
Roxadustat is also in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes.
Peony Yu, Chief Medical Officer, FibroGen, said: "With this approval in Japan, NDA approval in China, and EU MAA and US NDA preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anemia of chronic kidney disease, worldwide."
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