SL Vifor is pleased that its partner 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 an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.

"We congratulate our partner Akebia on the FDA approval, which represents an important moment in our shared efforts toward improving the lives of dialysis patients with anemia due to CKD in the U.S.," said Hervé Gisserot, General Manager of CSL Vifor. "As we continue to deliver on our promise for patients and public health, we are eager to closely collaborate with our partners to make this new oral treatment option available to patients." 

"Patients receiving maintenance dialysis would benefit from additional therapeutic options that can effectively increase and maintain hemoglobin concentrations within guideline-recommended target ranges," said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Division of Nephrology at Stanford University and Co-Chair of the independent Executive Steering Committee for PRO₂TECT and INNO₂VATE, the global Phase 3 clinical development programs for Vafseo.

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 2021; 384:1589-1600). See the Important Safety Information section below, including BOXED WARNING regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access. 

CSL Vifor has been granted an exclusive license to sell Vafseo to Fresenius Kidney Care dialysis centers and specific other third-party dialysis organizations in the U.S., allowing us to potentially reach approximately 60% of the dialysis patients in the country.