Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.
US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the European Medicines Agency (EMA) regulatory submission acceptance and approval of Duvroq in Japan
GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) 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.
The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial programme, 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. These trials demonstrated that daprodustat improved and/or maintained haemoglobin (Hb) within the target level (10-11.5 g/dL) without increased major adverse cardiovascular events (MACE) in the intention-to-treat (ITT) populations in each pivotal study, when compared to the standard of care, an erythropoietin stimulating agent (ESA), across both non-dialysis and dialysis patient settings.
Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia. In March 2022, the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, which is currently under review. Additional regulatory filings are anticipated to continue throughout 2022.
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