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GSK shares positive Phase III data for daprodustat
GSK shares positive Phase III data for daprodustat.
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[{"type":"text","content":"\n \n \n \n RNS Number : 5593R\n GlaxoSmithKline PLC\n 05 November 2021\n \n \n \n \n Issued: 5 November 2021, London UK\n \n \n \n \n \n \n \n \n \n GSK \n \n \n announces positive Phase III efficacy and safety data for daprodustat in patients with anaemia due to chronic kidney disease\n \n \n \n · \n Late-breaking data from the daprodustat ASCEND-ND and ASCEND-D trials at the American Society of Nephrology's Kidney Week 2021 confirms the potential for a new oral treatment for patients with anaemia due to chronic kidney disease in both non-dialysis and dialysis settings\n \n \n · \n Data from five Phase III studies demonstrated that daprodustat improved or maintained haemoglobin within target levels, without increased cardiovascular risk when compared to standard of care\n \n \n · \n Pivotal trials in non-dialysis and dialysis populations published simultaneously in the \n \n New England Journal of Medicine\n \n \n \n \n \n \n \n \n \n \n GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive results from the Phase III ASCEND (Anaemia Studies in Chronic Kidney Disease: Erythropoiesis via a novel prolyl hydroxylase inhibitor Daprodustat) programme for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), during a presentation at the American Society of Nephrology's Kidney Week 2021. The positive primary efficacy and safety results confirm the potential for daprodustat to be a new oral treatment for patients with anaemia due to chronic kidney disease (CKD) in both non-dialysis and dialysis settings. Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability.\n \n \n \n \n \n The ASCEND programme is comprised of five Phase III studies assessing the efficacy and safety of daprodustat for the treatment of anaemia due to CKD across the CKD disease course. The programme enrolled over 8,000 patients who were treated for up to 4.26 years\n . Daprodustat was well tolerated in both non-dialysis and dialysis populations as assessed in the primary analysis. Data on daprodustat, including results from the two pivotal Phase III studies focused on non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients, were shared at the American Society of Nephrology's meet...