Policy & Regulation
AstraZeneca and FibroGen provide update on FDA review of roxadustat
2 March 2021 -

Biopharmaceutical companies AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and FibroGen Inc (Nasdaq:FGEN) announced on Tuesday that the US Food and Drug Administration (FDA) is to convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat.

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is currently under regulatory review for the treatment of anaemia of chronic kidney disease (CKD).

AstraZeneca and FibroGen said that they 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 yet been set.

Roxadustat is already 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. The efficacy and safety of the drug have been demonstrated in a Phase III programme which included more than 8,000 patients.

AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US and other countries in the Americas, as well as China, Australia, New Zealand and Southeast Asia. Astellas Pharma Inc (TYO:4503) and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.

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