StockMarketWire.com - AstraZeneca said its drug to treat anaemia in non-dialysis-dependent patients suffering from chronic kidney disease had received marketing authorisation in China.

'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,' said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.

The application was filed by AstraZeneca's partner FibroGen (China) Medical Technology Development.

The approval, granted by the National Medical Products Administration, was primarily supported by a Phase III trial in non-dialysis-dependent-chronic kidney disease 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.






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