22nd Aug 2019 08:36
(Alliance News) - AstraZeneca PLC announced Chinese approval for roxadustat in non-dialysis-dependent patients on Thursday, as well as the USD95 million purchase of a priority review voucher in the US.
Astra partner FibroGen China Medical Technology Development Co Ltd has been granted marketing authorisation for roxadustat as a treatment for anaemia caused by chronic kidney disease in patients not on dialysis, making China the first country to do so.
The approval was granted by China's National Medical Products Administration on the back of a phase 3 trial where the drug was shown to produce a "statistically-significant improvement in haemoglobin levels".
The drug has already been approved in China to treat anaemia in chronic kidney disease patients on dialysis. Astra and FibroGen China will launch roxadustat in China in the second half of 2019.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astra, 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."
FTSE 100-listed pharma firm Astra has also agreed to pay USD95 million in cash for a US Food & Drug Administration priority review voucher.
The company will buy the voucher, which grants the holder a priority review by the FDA of either a biologics licence or a new drug application, from a subsidiary of Swedish Orphan Biovitrum AB publ.
The deal must still be cleared under the Hart-Scott Rodino Antitrust Improvements Act.
Shares in Astra were up 0.2% at 7,428.00 pence on Thursday morning in London.
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