FDA Approves Vadadustat for Treatment of Anemia Due to CKD in Adults on Dialysis

The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) to treat anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 3 months. Vafseo is now approved in 37 countries.

The once-daily tablet is a hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. It was developed by Akebia Therapeutics, a biopharmaceutical company focused on therapies for kidney disease.

“With the approval of Vafseo in the US, we’re proud to deliver an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anemia due to CKD,” said John P. Butler, chief executive officer of Akebia. Approximately 500,000 US adults on dialysis experience anemia due to CKD. Most are treated for anemia with injectable erythropoiesis-stimulating agents administered primarily at dialysis centers.

Vafseo’s approval was based on efficacy and safety data from the INNO2VATE program and an evaluation of post-marketing safety data from Japan. INNO2VATE results appeared in the New England Journal of Medicine [2021;384(1601-12) and 2021;384(1589-1600)].

The boxed warning for Vafseo will highlight an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.