Astellas files for roxadustat approval in Japan
Japanese pharma major Astellas Pharma (TYO: 4503) today revealed that it has submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis.
The results obtained from four Phase III studies conducted in CKD patients on dialysis in Japan support this NDA submission.
Roxadustat is licensed from FibroGen (Nasdaq: FGEN), which is collaborating with AstraZeneca (LSE: AZN) over the development and commercialization the drug in China, the USA, and other markets.
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