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Roxadustat approved in China for the treatment of
Roxadustat approved in China for the treatment of.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8927J AstraZeneca PLC 22 August 2019 \n\n22 August 2019 07:00 BST\n \nRoxadustat approved in China for the treatment of anaemia in \nnon-dialysis-dependent patients with chronic kidney disease\n \nChina is the first country to approve roxadustat for all\n chronic kidney disease patients with anaemia\n \nAstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients. \n \nThis approval, granted by the National Medical Products Administration, is primarily supported by a Phase III trial in NDD-CKD patients with anaemia, in which roxadustat demonstrated a statistically-significant improvement in haemoglobin levels from baseline averaged over weeks seven to nine of treatment, with a mean change of 1.9 g/dL compared to -0.4 g/dL with placebo. This data was published in The New England Journal of Medicine in July 2019.\n \nThis marketing authorisation follows the approval of roxadustat in China in December 2018 for anaemia in CKD patients who are on dialysis. AstraZeneca and FibroGen China expect to launch roxadustat in China during the second half of 2019.\n \nMene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: \"With this approval for roxadustat in China, we are now able to provide this first-in-class medicine to all patients living with chronic kidney disease who experience anaemia, regardless of whether they require dialysis. This is a significant milestone and we look forward to bringing the medicine to patients later this year.\"\n \nAnaemia caused by CKD is associated with cardiovascular disease, hospitalisation, cognitive impairment and reduced quality of life, and has been shown consistently to increase the risk of death in patients with CKD.1 Anaemia becomes increasingly common in patients with CKD as their disease progresses.1\n \nAbout roxadustat\nRoxadustat is a first-in-class, orally-administered small-molecule currently approved in China for the treatment of patients with anaemia from CKD on dialysis and not on dialysis. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor that promote...