Positive Phase III results for roxadustat in CKD patients with anemia and not on dialysis.-Astellas
Astellas Pharma Inc. has announced that roxadustat, an inhibitor of hypoxia �inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase III ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 521. The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in CKD patients with anemia.
The ALPS study is the first of three Astellas Phase III studies conducted mainly in EMEA to report. The study forms part of a wider large-scale global Phase III development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. and will ultimately support filing and reimbursement in Europe. The ALPS study is a randomized, double-blind, placebo-controlled study of the efficacy and safety of roxadustat for the treatment of anemia in CKD in patients not on dialysis.
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