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AstraZeneca granted marketing authorisation for Roxadustat in China

By Iain Gilbert

Date: Thursday 22 Aug 2019

AstraZeneca granted marketing authorisation for Roxadustat in China

(Sharecast News) - Biopharmaceutical company AstraZeneca has received marketing authorisation for Roxadustat in China for the treatment of anaemia caused by chronic kidney disease in non-dialysis-dependent patients.
The approval, granted to its Chinese partner FibroGen Medical Technology Development, follows the approval of Roxadustat in the Asian nation in December 2018 for anaemia in CKD patients who were on dialysis.

Roxadustat had previously demonstrated a \"statistically significant improvement\" in haemoglobin levels from baseline over weeks seven to nine of its phase III trial in non-dialysis-dependent patients.

AstraZeneca and FibroGen expect to launch Roxadustat in China during the second half of 2019.

Mene Pangalos, AstraZeneca\'s vice President of biopharmaceuticals research and development, 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.\"

In a separate announcement, AstraZeneca revealed it had agreed to buy a US Food and Drug Administration priority review voucher from a subsidiary of Swedish Orphan Biovitrum.

The voucher, which AstraZeneca purchased for $95.0m, entitles the group to FDA priority review of a single new drug application or biologics license application, reducing the target review time and potentially leading to an expedited approval.

As of 0820 BST, AstraZeneca shares had ticked up 0.12% to 7,421p.


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