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.
Further, FibroGen and Astellas are in development and commercialisation deal for roxadustat for the potential treatment of anaemia in Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.
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 and published in five peer-reviewed journals. The Phase III programme included more than 8,000 patients and was conducted by AstraZeneca, FibroGen and Astellas.
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.
In the after hours trading on Nasdaq, FibroGen shares were losing around 20.6 percent.
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