On the heels of China approval, FibroGen and AstraZeneca spotlight more positive PhIII data for roxadustat
Days after FibroGen and AstraZeneca scored their first approval for roxadustat — in China — the partners say they have more Phase III data to support their upcoming pitches in the US and other countries.
The anemia drug hit the primary endpoints of both OLYMPUS and ROCKIES: A statistically significant improvement in mean change from baseline in Hb levels averaged over weeks 28 to 52.
The two trials differ in two main aspects: In OLYMPUS, the chronic kidney disease patients are not dependent on dialysis, and the comparator arm consists of a placebo; while ROCKIES involve dialysis-dependent patients and compares roxadustat against epoetin alfa, an analog of the naturally occurring erythropoietin.
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