(Alliance News) - AstraZeneca PLC and FibroGen Inc on Monday said a US regulator will convene a committee meeting to review the new drug application for roxadustat.
Cambridge, England-based biopharmaceutical company Astra and San Francisco, California-based FibroGen are collaborating on the development of roxadustat, which is intended to treat anaemia of chronic kidney disease.
The US Food & Drug Administration will convene the Cardiovascular & Renal Drugs Advisory Committee meeting to review the application for the drug. This follows a December FDA decision to extend the review period for roxadustat in order to carry out further analysis of study data.
"AstraZeneca and FibroGen are committed to working with the FDA ahead of the meeting and to bringing roxadustat to patients with anaemia of [chronic kidney disease]. A date for the advisory committee meeting has not been determined," said Astra.
The drug is already approved in China to treat anaemia in chronic kidney disease in non-dialysis dependent and dialysis-dependent adults patients, as well as in Japan and Chile. It is under regulatory review elsewhere, including in the EU.
By Anna Farley; annafarley@alliancenews.com
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