AstraZeneca, FibroGen: FDA Panel To Review Roxadustat

 AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that the US Food and Drug Administration or FDA informed FibroGen, Inc. 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 or CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients..

AstraZeneca said the company and FibroGen are working with the FDA ahead of the meeting and to bring roxadustat to patients with anaemia of CKD. A date for the advisory committee meeting has not been determined.

AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other countries in the Americas, Australia and New Zealand, as well as Southeast Asia.

https://www.nasdaq.com/articles/astrazeneca-fibrogen%3A-fda-to-convene-committee-meeting-to-review-roxadustat-in-anaemia-of