Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis. Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review. The U.S. Food and Drug Administration issued a complete response letter for the roxadustat NDA filing for the treatment of CKD anemia in August 2021. Roxadustat is in Phase 3 clinical development in the U.S., Europe, and China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia (CIA). The goal of these clinical studies is to evaluate the safety and efficacy of the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor therapy for the treatment of anemia.
Anemia Associated with Myelodysplastic Syndromes
MATTERHORN Study – FG-4592-082, Phase 3, Anemia in Myelodysplastic Syndrome (MDS) Patients
For more information on the study, please contact