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AstraZeneca, FibroGen say FDA to review anaemia of chronic kidney disease drug application
StockMarketWire.com
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Drugmakers AstraZeneca and FibroGen said the US Food and Drug Administration would meet with the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for a drug used to treat anaemia of chronic kidney disease.
A date for the advisory committee meeting had not been determined.
The efficacy and safety of roxadustat had been demonstrated in the phase III programme including more than 8,000 patients and published in five peer-reviewed journals.
Story provided by StockMarketWire.com
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