FibroGen Announces Positive Data From Phase 3 Study Of Roxadustat For Treatment Of Anemia

(RTTNews) - FibroGen Inc. (FGEN) announced positive data from its Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China.

Roxadustat demonstrated non-inferiority compared to recombinant erythropoietin alfa (SEPO) on the primary endpoint of change in hemoglobin (Hb) level from baseline to the average level during weeks 9-13.

In the preliminary safety analysis, the adverse event profile of roxadustat was generally consistent with previous findings and supportive of a positive benefit risk in this patient population.

The Phase 3 study is sponsored and conducted by FibroGen and is part of the collaboration with AstraZeneca. FibroGen will work with AstraZeneca and the China Health Authority to file the supplemental New Drug Application.

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