AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (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.
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