GSK Daprodustat bags USFDA review to treat anemia of CKD
Daprodustat, a HIF-PHI, belongs to a novel class of oral medicines indicated for the potential treatment of anemia of CKD in adult patients not on dialysis and on dialysis.;
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London: GlaxoSmithKline plc has announced that the US Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).
Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 1 February 2023.
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