Vadadustat Approved for CKD-Related Anemia in Patients on Dialysis by FDA

The US Food and Drug Administration (FDA) has approved vadadustat (Vafseo) to treat anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months, according to developer Akebia Therapeutics.

Vadadustat is a once-daily hypoxia-inducible factor prolyl hydroxylase inhibitor tablet that activates endogenous production of erythropoietin to manage anemia.

“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 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.

Vadadustat approval was based on efficacy and safety data from the INNO2VATE trial and an evaluation of postmarketing safety data from Japan. The boxed warning for vadadustat will note an increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.