Posted by Michael Wonder on 22 Aug 2019
Roxadustat approved in China for the treatment of anaemia in non-dialysis-dependent patients with chronic kidney disease
22 August 2019 - China becomes the first country to approve roxadustat for all chronic kidney disease patients with anaemia
AstraZeneca today announced that its partner FibroGen 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.
This 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.
