21st Dec 2020 07:29
(Alliance News) - AstraZeneca PLC on Friday said the US Food & Drug Administration has extended the review period of its anaemia drug roxadustat in order to carry out further analysis of the study data.
Roxadustat - which is being developed by FTSE 100 Anglo-Swedish drug manufacturer Astra and US biotechnology company Fibrogen Inc as a treatment of anaemia in patients with chronic kidney disease - promotes red blood cell production through the increased production of erythropoietin, improved iron absorption and downregulation of hepciden, the company explained.
Erythropoietin is a hormone produced by the kidneys to stimulate production and maintenance of red blood cells. Hepciden is a protein which regulates iron metabolism.
AstraZeneca said the regulator has extended the review period of the New Drug Application for roxadustat to March 20, 2021 from December 20, 2020 after FibroGen submitted additional analysis of clinical data for the drug.
Roxadustat is already approved in China under the name Evrenzo and in Chile.
By Ife Taiwo; [email protected]
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