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StockMarketWire.com AstraZeneca has announced the US Food and Drug Administration (FDA) has issued a complete response letter regarding its new drug application for roxadustat.
Roxadustat is a treatment of anaemia of chronic kidney disease, in both non-dialysis dependent and dialysis-dependent adult patients.
The CRL requested an additional clinical trial on the safety of roxadustat in both the NDD and DD patient populations.
AstraZeneca is working with its partner FibroGen and the FDA to evaluate its next steps.
Roxadustat is approved in a number of countries, including China and Japan, for the treatment of anaemia in CKD in NDD and DD adult patients. It is under regulatory review in other jurisdictions, including in the European Union.
At 3:05pm: (LON:AZN) Astrazeneca PLC share price was 0p at 8633p