Posted by Michael Wonder on 19 Apr 2022
US Food and Drug Administration accepts new drug application for daprodustat
19 April 2022 - Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase 3 clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.
GlaxoSmithKline today announced that the US FDA accepted the new drug application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the potential treatment of patients with anaemia of chronic kidney disease (CKD).
The FDA has assigned a Prescription Drug User Fee Act action date of 1 February 2023.
