|FibroGen Announces China FDA Approval of CTA to Conduct Pivotal Phase 2/3 Clinical Trial of Roxadustat in Anemia Associated With Lower Risk MDS|
This Phase 2/3 clinical trial will evaluate the safety and efficacy of roxadustat in non-transfusion dependent, lower risk MDS patients with anemia. The initial open-label portion of the study is expected to enroll up to 40 patients, with 135 patients planned for the randomized, double-blind, placebo-controlled Phase 3 portion of the study, in which subjects will be randomized 2:1 to receive roxadustat or placebo three-times-weekly (TIW) for 26 weeks. The Company expects to initiate this Phase 2/3 study in the second half of 2017.
In addition, the Company anticipates initiating a U.S. Phase 3 MDS clinical trial in the third quarter of 2017. The pivotal U.S. study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of roxadustat for the treatment of anemia in transfusion-dependent lower risk MDS patients.
About MDS Anemia in
Roxadustat is currently advancing through Phase 3 clinical trials worldwide, supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. To date, roxadustat has been evaluated in Phase 1 and Phase 2 studies, involving more than 1,400 subjects. Globally, a total of 15 Phase 3 studies, with target enrollment of about 10,000 patients worldwide, are currently being conducted to support independent regulatory approvals of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients in the U.S.,