AstraZeneca PLC’s (LON:AZN) roxadustat anaemia drug has secured another regulatory approval in China.
Just before Christmas last year, the FTSE 100 drugmaker was given the green light to start treating Chinese anaemia patients on dialysis whose condition had been caused by chronic kidney disease.
READ: AstraZeneca’s remarkable drug pipeline turnaround continues
It has now been told it can start treating non-dialysis-dependent (NDD) patients.
Regulators approved the drug on the back of a phase III trial, in which roxadustat helped to boost haemoglobin count in NDD patients by a “statistically significant” amount.
Astra, along with its partner, FibroGen, expect to launch the drug in China later this year.
“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 Astra’s BioPharmaceuticals R&D boss, Mene Pangalos.
“This is a significant milestone and we look forward to bringing the medicine to patients later this year.”
Buys FDA Priority Review Voucher for US$95mln
In a separate statement, AstraZeneca confirmed it has bought a US Food and Drug Administration Priority Review Voucher from Swedish rare disease specialist Sobi for US$95mln.
PRVs entitle the holder to a priority review of a new drug application or biologics license application, which reduces the amount of time taken by regulators to review the drug and can potentially lead to expedited approval.
They are handed out to drug developers to encourage them to start researching treatments that they might otherwise not pursue.
Astra shares were up 0.5% to 7,446p on Thursday morning, just shy of their all-time high.