FibroGen, AstraZeneca ready China application as anemia drug scores in two pivotal studies
Fibrogen $FGEN and AstraZeneca $AZN took a big step toward completing their new drug application in China for the anemia drug roxadustat after hitting the primary endpoints in two Phase III studies in the key Asian market.
Chronic kidney disease patients taking roxadustat (FG-4592 or 罗沙司他) gained a mean average of 1.9g/dL in hemoglobin levels, compared to a drop of -0.4g/dL in the placebo group. And 84% of the patients had a significant increase in hemoglobin response, compared to none in the placebo arm.
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