Two phase III studies of FG 4592 (roxadustat) in anemia meet primary endpoints- FibroGen
FibroGen has reported positive topline results from the two Phase III clinical studies of FG-4592 (roxadustat) in anemia designed to support new drug application submission in China. Both of the Phase III studies met their primary efficacy endpoints, which were evaluated in the comparator-controlled portions of the studies. In the double-blind, placebo-controlled eight-week portion of the 26-week NDD-CKD trial, 151 anemia patients were randomized 2:1 to receive roxadustat (n=101) or placebo (n=50).
Roxadustat met its primary efficacy endpoint of correcting anemia, by achieving a statistically significant increase in hemoglobin (Hb) levels compared to placebo over eight weeks. Furthermore, the secondary endpoint of Hb response was met as Hb response was achieved by a higher proportion of patients in the roxadustat arm than in the placebo arm.
In the dialysis study, 304 patients (271 hemodialysis and 33 peritoneal dialysis patients) previously on epoetin alfa were randomized to and treated with roxadustat (n=204) or epoetin alfa (n=100) for 26 weeks. All the patients randomized to the active comparator arm were treated with epoetin alfa. The primary endpoint was Hb change from baseline to the Hb level averaged during the final five weeks of the 26-week treatment period. Roxadustat met the predefined non-inferiority criterion for its primary endpoint in comparison to Kirin EPO in both full analysis set (FAS) and per protocol set (PPS) analyses.
Furthermore, on superiority testing of the primary endpoint, the mean Hb increase observed in the roxadustat arm was higher than in the Kirin EPO arm, 0.75g/dL vs. 0.46g/dL (p=0.037) in PPS analysis. Initial findings suggest that adverse events were consistent with previous clinical trials of roxadustat in the CKD patient population with no new or unexpected safety signals identified. The 52-week safety assessment in at least 100 patients is ongoing with expected study completion in June 2017.
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