US FDA accepts NDA for daprodustat
UK pharma major GlaxoSmithKline (LSE: GSK) today announced that the US Food and Drug Administration 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 anemia 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 February 1, 2023.
The daprodustat NDA is based on positive results from the ASCEND Phase III clinical trial program, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anaemia across the spectrum of CKD. Results from the key cardiovascular outcomes trials were published in the New England Journal of Medicine in November 2021 and included non-dialysis ( ASCEND-ND) and dialysis ( ASCEND-D) CKD patients.
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