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FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

July 15, 2021


AZ and FibroGen are aiming for approval of roxadustat for the treatment of anaemia caused by chronic kidney disease (CKD).

In briefing documents published ahead of a meeting of the Cardiovacular and Renal Drugs Advisory Committee meeting on 15 July, the FDA said that “roxadustat’s efficacy is not in question”.

However, the document added that “the principal issues before the committee are the drug’s safety, and safety with respect to the specific CKD populations”.

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