11th Aug 2021 14:51
(Alliance News) - AstraZeneca PLC on Wednesday said US regulator requested an additional clinical trial on the safety of roxadustat in both the non-dialysis dependent and dialysis-dependent patient populations.
The drugmaker said it is working with its partner FibroGen Inc and the US Food & Drug Administration to evaluate next steps.
The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, have been demonstrated in the phase III programme including more than 8,000 patients.
Roxadustat is approved in a number of countries, including China and Japan, for the treatment of anaemia. It is under regulatory review in other jurisdictions, including in the EU, where it has recently received a positive opinion.
AstraZeneca shares were trading 0.4% higher in London on Wednesday at 8,182.00 pence each.
By Evelina Grecenko; [email protected]
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