Akebia Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. The approval of Vafseo for the treatment of anemia Due to CKD in adults who have been receiving Dialysis for at least three months is based on efficacy and safety data from the INNO2VATE program and an assessment of post marketing safety data from Japan where VAFSEO was launched in August 2020.

Results from the INNO2Vate program were published in the New England Journal of Medicine: (N Engl J Med 2021; 384:1601-1612); (N Engl J Med 2022; (N Engl JMed 2021;384:1589-1600). most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.