Akebia Therapeutics Provides Update on Vafseo for Non-Dialysis Patients

Core Viewpoint - Akebia Therapeutics does not plan to initiate the VALOR clinical trial for vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis, following feedback from the U.S. FDA indicating a need for a larger patient population and increased time and costs for the trial [1][2][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4] Product Information - Vafseo® (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treating anemia due to CKD in adults who have been on dialysis for at least three months, with approval in 37 countries [5] Regulatory Feedback - The FDA's feedback from the Type C meeting suggests that regulatory alignment for the VALOR trial would necessitate a significantly larger patient cohort than initially proposed, leading to increased time and costs [2][3] Future Directions - Despite the setback with the VALOR trial, the company remains committed to addressing the unmet need for oral anemia treatment in CKD patients not on dialysis and is exploring potential clinical trial designs for smaller subgroups of CKD patients [3]