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Roxa Adcom Votes Overwhelmingly Against Approval in NDD (1-13) and DD (2-12)
Today, FDA held an advisory committee meeting to discuss the proposed roxadustat indication for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. The panel voted 1-13 and 2-12 against either NDD or DD approval, respectively. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for AZ/Fibrogen and Akebia/Otsuka’s vadadustat.