Posted by Michael Wonder on 11 Aug 2021
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
11 August 2021 - The US FDA has issued a complete response letter regarding the new drug application for roxadustat for the treatment of anaemia of chronic kidney disease, in both non-dialysis dependent and dialysis-dependent adult patients.
The complete response letter requested an additional clinical trial on the safety of roxadustat in both the non-dialysis dependent and dialysis-dependent patient populations.
