Akebia Therapeutics, Inc. (Nasdaq: AKBA) has announced the near-complete coverage of U.S. dialysis patients with commercial supply contracts for Vafseo® (vadadustat), a treatment for anemia due to chronic kidney disease (CKD). Simultaneously, the company is advancing plans for a Phase 3 trial to broaden Vafseo's label to include non-dialysis CKD patients. These developments signal a potentially transformative year for Akebia, according to CEO John P. Butler, with Vafseo poised to become a new standard of care.
Vafseo Commercial Availability
As of January 2025, Vafseo tablets are shipping to dialysis centers across the U.S., making the drug available to adult patients with anemia due to CKD who have been receiving dialysis for at least three months. Akebia has secured commercial supply agreements with dialysis organizations that collectively treat nearly 100% of dialysis patients in the U.S. This broad access is further supported by the Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement, as directed by the Centers for Medicare & Medicaid Services (CMS).
Planned Phase 3 Trial for Non-Dialysis CKD Patients
Building on the FDA's acknowledgement of an unmet need for safer, orally available therapies for anemia in non-dialysis CKD patients, Akebia is planning a Phase 3 cardiovascular outcome study. The trial will involve approximately 1,500 U.S. subjects with late-stage CKD anemia who are not on dialysis and is expected to commence in mid-2025. Akebia has received feedback from the FDA on its protocol submission and plans to request a Type C meeting to discuss the statistical analysis plan and regulatory path forward.
Market Reception and Future Outlook
Akebia's market research suggests strong interest from nephrologists in prescribing Vafseo. According to the research, 99% of nephrologists would consider prescribing Vafseo to certain eligible patients, with 75% intending to do so within six months of product availability. This positive reception, combined with the potential label expansion into the non-dialysis population, represents a significant market opportunity for Akebia.
John P. Butler, Chief Executive Officer of Akebia, stated, "We believe Akebia is entering a transformational year with the U.S. market availability of Vafseo, which we believe could become a new standard of care for patients with CKD. During 2025 our commercial organization will remain focused on executing the U.S. launch of Vafseo, while our development team pursues label expansion of Vafseo into the non-dialysis population, which represents a potential multiple billion-dollar market opportunity in the U.S."
Financial Stability
Akebia anticipates that its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including the U.S. Vafseo launch and planned pipeline advancement, for at least two years.
