Research & Development
Astellas Pharma and FibroGen files European MAA for roxadustat with for treating anemia in adult patients with CKD
21 May 2020 -

Japanese healthcare company Astellas Pharma Inc (TSE:4503) and US-based FibroGen Inc (Nasdaq:FGEN) announced on Wednesday that they have submitted the marketing authorization application (MAA) for roxadustat to the European Medicines Agency (EMA) for the treatment of anemia in adult patients with chronic kidney disease (CKD).

Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl­ hydroxylase (PH), which increases hemoglobin levels with a mechanism of action that is different from that of erythropoiesis-stimulating agents.

This European MAA is supported by positive results from the partnership's pivotal Phase 3 programme, which involved 9,000 patients worldwide. The results support roxadustat as efficacious in increasing and maintaining target hemoglobin levels with reduced use of intravenous iron in adult patients with CKD anemia, both those who are dialysis dependent (DD) and those non-dialysis dependent (NDD).

The EMA's acceptance of the roxadustat MAA for treatment of anemia in patients with CKD on dialysis and not on dialysis triggers a milestone payment of USD130m by Astellas to FibroGen.

CKD is a progressive loss of kidney function and the associated anemia results from the failing kidneys' ability to produce erythropoietin, which stimulates red blood cell production in the bone marrow.