Astellas strengthens hand ahead of Japanese roxadustat filing

31 May 2018

Japanese pharma major Astellas (TYO: 4503) and its partner FibroGen (Nasdaq: FGEN) are edging in on an approval of roxadustat in hemodialysis chronic kidney disease (CKD) patients with anemia.

In a fourth Phase III study of roxadustat in Japan, the treatment met its primary endpoint of showing non-inferiority in change in average hemoglobin levels to darbepoetin alfa (genetical recombination) in hemodialysis-dependent CKD patients with anemia who had been previously treated with recombinant human erythropoietin or darbepoetin alfa.

The results are consistent with previously reported data from roxadustat Phase III studies in Japan and in China, and from an extensive Phase II program.

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