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China FDA accepts FibroGen's application for anemia treatment

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China FDA accepts FibroGen's application for anemia treatment

The China Food and Drug Administration accepted FibroGen Inc.'s new drug application for roxadustat.

Roxadustat is indicated for treating anemia, a deficiency of red blood cells, in patients with dialysis-dependent chronic kidney disease, or CKD, and non-dialysis-dependent CKD.

The new drug application submission also triggered a $15 million milestone payment from AstraZeneca PLC payable to FibroGen under a deal between the two companies. FibroGen is co-developing roxadustat with AstraZeneca.

The application is based on the results of two phase 3 studies.