Advisory Committee Meeting to be held to review NDA for daprodustat to treat anaemia due to chronic kidney disease
GSK plc announced that the FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) under regulatory review for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis
GSK is committed to working closely with the FDA to bring daprodustat to appropriate patients with anaemia of CKD. A date for the Advisory Committee meeting is set for 26 October 2022.
The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial programme, which included five pivotal studies assessing the efficacy and safety of daprodustat for the treatment of anaemia across the spectrum of CKD. Results from the key cardiovascular outcomes studies 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 studies demonstrated that daprodustat improved and/or maintained haemoglobin (Hb) within the target level (10-11.5 g/dL), and the primary safety analysis of the intention-to-treat (ITT) populations showed that daprodustat achieved non-inferiority of MACE (major adverse cardiovascular events) compared to the standard of care, an erythropoietin stimulating agent (ESA), across both non-dialysis and dialysis patient settings.
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