AstraZeneca has announced that in China FibroGen has received the market authorization for roxadust. The drug is indicated for treating the patients suffering from anemia caused by chronic kidney disease in non-dialysis dependent patients.
The National Products Administration granted approval based on the Phase III trial. In the trial, the roxadust has significantly increased the hemoglobin levels. The mean change of hemoglobin levels from baseline was 1.9 g/dL compared to -0.4 g/dL with placebo after seven to nine weeks of treatment.
AstraZeneca and FibroGen are planning to launch the product in the second half of 2019.
Anemia in CKD causes cardiovascular diseases, hospitalization, decreased quality of life. Anemia became common in patients suffering from chronic kidney disease.