The FDA will convene an Advisory Committee meeting to review the NDA for roxadustat to treat anemia of CKD – AstraZeneca + FIbroGen Inc

AstraZeneca and FibroGen, Inc. announced that the FDA informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anaemia of chronic kidney disease (CKD).

AstraZeneca and FibroGen are committed to working with the FDA ahead of the meeting and to bringing roxadustat to patients with anaemia of CKD. A date for the advisory committee meeting has not been determined. The efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the pivotal Phase III programme including more than 8,000 patients and published in five peer-reviewed journals.

Roxadustat is approved in China, Japan and Chile for the treatment of anaemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients, and is under regulatory review in the EU and other jurisdictions.