Roxadustat: Ph III FGCL-4592-806 data

Top-line data from the open-label, Chinese Phase III FGCL-4592-806 trial in 304 dialysis-dependent CKD patients whose anemia was previously treated with epoetin alfa showed that thrice-weekly oral roxadustat met the primary endpoint of non-inferiority to epoetin alfa in the change from baseline in hemoglobin levels to the mean of the final 5 weeks of the 26-week treatment period. In the per protocol (PP) population, roxadustat led to a significantly greater mean hemoglobin increase vs. epoetin alfa (0.75 vs. 0.46 g/dL, p=0.037). The trial compared roxadustat to a biosimilar epoetin alfa from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151, Tokyo, Japan) that is marketed in China. The trial includes an open-label extension...