FibroGen CKD therapy clears Phase III hurdle in China

FibroGen Inc. (NASDAQ:FGEN) said roxadustat (FG-4592) met the primary endpoints in two Chinese Phase III trials to treat anemia in chronic kidney disease (CKD) patients. The company intends to submit an NDA to China FDA this year in the indication.

One study, FGCL-4592-808, evaluated roxadustat in non-dialysis-dependent patients. The candidate significantly increased hemoglobin levels from baseline to week 8 vs. placebo (increase of 1.9 g/dL vs. reduction of 0.4 g/dL, p<0.00001), meeting the primary endpoint. The 26-week study enrolled 151 patients...