FDA approves Akebia Therapeutics’ Vafseo

CSL Vifor’s partner Akebia Therapeutics has received the Food and Drug Administration’s blessing for Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.

Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor 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 Chertow, 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.

[Read more: CVS Health Clinical Trial Services to recruit diabetes, chronic kidney disease patients]

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 United States, allowing us to potentially reach approximately 60% of the dialysis patients in the country.