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Update on US review of roxadustat
Update on US review of roxadustat.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3422I\n AstraZeneca PLC\n 11 August 2021\n \n \n \n 11 August 2021 14:35 BST\n \n \n \n Update on US regulatory review of \n \n \n roxadustat \n \n \n \n in anaemia of chronic kidney disease\n \n \n \n \n \n The US Food and Drug Administration (FDA) has \n issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.\n \n \n \n \n The CRL requested an additional clinical trial on the safety of roxadustat in both the NDD and DD patient populations.\n \n \n AstraZeneca is working with its partner FibroGen, Inc. (FibroGen) and the FDA to evaluate next steps.\n \n \n \n The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients \n and published in five peer-reviewed journal articles. \n \n \n \n \n \n Roxadustat is approved in a number of countries, including China and Japan, for the treatment of anaemia in CKD in NDD and DD adult patients. It is under regulatory review in other jurisdictions, including in the European Union, where it has recently received a positive \n \n CHMP opinion\n \n .\n \n \n \n Anaemia\n \n Anaemia can be a serious medical condition in which patients have insufficient red blood cells (RBCs) and low levels of haemoglobin, a protein in RBCs that carries oxygen to cells throughout the body.1 Anaemia of CKD frequently causes significant fatigue, cognitive dysfunction and decreased quality of life, and is associated with increased risk of hospitalisation, CV complications and death.1,2 Severe anaemia is common in patients with CKD, cancer, myelodysplastic syndrome (MDS), inflammatory diseases and other serious illnesses. Anaemia is particularly prevalent in patients with CKD.2,3,4 CKD affects 840 million patients worldwide and is generally progressive, characterised by gradual loss of kidney function that may eventually lead to kidney failure.5,6\n \n \n \n \n Phase III programme\n \n \n The Phase III programme included more than 8,000 patients and was conducted by AstraZeneca, FibroGen and Astellas Pharma Inc. (Astellas). The...