Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced multiple positive business updates. As of January, Vafseo tablets are available in the U.S. for adult patients with anemia due to chronic kidney disease (CKD) on dialysis for at least three months, and shipment of product to dialysis centers has commenced. In addition, Akebia recently signed a Vafseo commercial supply agreement with a leading dialysis organization. Akebia now has contracts in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. As previously announced, Vafseo qualifies for the Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement as directed by the Centers for Medicare & Medicaid Services (CMS), and CMS has published billing guidance and reimbursement rates.
Akebia also announced its plans to begin a Phase 3 trial for the use of vadadustat in treating anemia in late-stage CKD patients who are not on dialysis. Akebia received feedback from the U.S. Food and Drug Administration (FDA) on its protocol submission for a label expansion study and is incorporating feedback as appropriate. Akebia expects to begin the trial in mid-2025.
“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,” said John P. Butler, Chief Executive Officer of Akebia. “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. We believe our commercial products and pipeline have the potential to generate significant shareholder value as Akebia strengthens its leadership position in the treatment of kidney disease and the hypoxia-inducible factor (HIF) space.”
Vafseo Commercial Update:
- Vafseo began shipping to dialysis centers and authorized distributors on January 9, 2025.
- Akebia has secured broad access for Vafseo as the company has now entered into commercial supply agreements with dialysis organizations treating nearly 100% of patients on dialysis in the U.S., including recently signing agreements with a leading dialysis organization and a mid-size dialysis provider.
- Akebia market research suggests 99% of nephrologists would consider prescribing Vafseo to certain eligible patients, with 75% intending to do so by 6 months after product availability.
- In December 2024, Akebia announced that U.S. Renal Care enrolled the first patients in the VOICE collaborative clinical trial of Vafseo. U.S. Renal Care has now enrolled more than 650 patients in the trial.
Planned Phase 3 Trial of Vadadustat in U.S. Non-Dialysis CKD Patients:
- In March 2024, the FDA approved Vafseo for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.
- The FDA acknowledged an unmet need for safer and orally available therapies to treat anemia due to CKD in certain non-dialysis patients.
- Akebia has since engaged with the FDA on potentially expanding vadadustat treatment to this patient population and has received feedback on a protocol submitted for a Phase 3 cardiovascular outcome study of approximately 1,500 U.S. subjects with late-stage CKD anemia not on dialysis, which is expected to begin in mid-2025.
- Akebia plans to request a Type C meeting with the FDA to continue to discuss the statistical analysis plan and regulatory path.
- Akebia expects 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.
Presentation at 43rd J.P. Morgan Healthcare Conference
John Butler, Chief Executive Officer, will present on Thursday, January 16th, 2025 at 7:30 a.m. PST. A webcast of the presentation can be accessed through the “Investors” section of Akebia’s website for 30 days following the conference.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.
