AstraZeneca and Fibrogen announced FDA issued a CRL regarding the roxadustat NDA for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. Recall, in July 2021, FDA held an advisory committee that voted 1-13 and 2-14 against the approval of roxadustat for the NDD and DD populations, respectively (previous FENIX insight). According to the press release, FDA is requesting additional clinical study be performed prior to resubmitting the roxadustat application. AZ and Fibrogen are working with FDA to evaluate next steps.