Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

Core Viewpoint - Akebia Therapeutics has received FDA approval for Vafseo (vadadustat) Tablets, a once-daily oral HIF-PH inhibitor for treating anemia due to chronic kidney disease (CKD) in adults on dialysis for at least three months, aiming to establish a new oral standard of care for this patient population [1][2][9]. Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, headquartered in Cambridge, Massachusetts, and founded in 2007 [8]. - The company plans to leverage its established commercial team and partnerships, particularly with CSL Vifor, to effectively launch Vafseo in the U.S. [4]. Product Details - Vafseo is indicated for adults with anemia due to CKD who have been on dialysis for a minimum of three months and is now approved in 37 countries [1][9]. - The approval is based on data from the INNO2VATE clinical program and post-marketing safety data from Japan, where Vafseo was launched in August 2020 [2][3]. Market Context - Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD, which can lead to significant healthcare costs and adverse clinical outcomes [3]. - Current treatments primarily involve injectable erythropoiesis-stimulating agents administered at dialysis centers, indicating a need for additional oral therapeutic options [3]. Clinical Significance - The introduction of Vafseo is seen as a promising alternative for managing anemia in CKD patients, potentially improving their quality of life [4]. - The product aims to stimulate endogenous erythropoietin production, thereby increasing hemoglobin and red blood cell levels [9]. Future Plans - Akebia will host a conference call on March 28, 2024, to discuss the approval and launch strategy for Vafseo [6][7].