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GSK provides update on FDA review of daprodustat
GSK provides update on FDA review of daprodustat.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 6 September 2022, London UK\n \n \n \n \n \n \n \n \n GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease\n \n \n \n \n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that\n the US Food and Drug Administration (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\n anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.\n \n \n \n \n \n GSK is committed to working closely with the US FDA to bring daprodustat to appropriate patients with anaemia of CKD. A date for the Advisory Committee meeting is set for 26 October 2022.\n \n \n \n \n \n \n Chris Corsico, Senior Vice President, Development, GSK said:\n \n \"We believe daprodustat and the results demonstrated in the ASCEND clinical trial programme have significant potential for patients living with anaemia of CKD who currently do not have an oral treatment option. We look forward to participating in the upcoming Advisory Committee meeting and working with the US FDA to complete its assessment of daprodustat, with the goal of bringing this innovative new treatment to appropriate patients in the US.\"\n \n \n \n \n \n The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial programme, which included five pivotal\n 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 (\n \n \n ASCEND-ND\n \n \n ) and dialysis (\n \n \n ASCEND-D\n \n \n ) CKD patients. These studies demonstrated that daprodustat improved and/or maintained haemoglobin (Hb)\n within the target level (10-11.5 g/dL),\n 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 patie...