EMA accepts marketing authorisation application for daprodustat to treat anaemia of chronic kidney disease – GSK

GlaxoSmithKline plc announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the 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 MAA includes positive data 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 course 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) patients.

These studies demonstrated that daprodustat improved and/or maintained haemoglobin (Hb) within target level (10-11.5 g/dL) without increased major adverse cardiovascular events (MACE) in the intention-to-treat populations in each pivotal study, compared to the standard of care, an erythropoietin stimulating agent (ESA), across both non-dialysis and dialysis patient settings.