FDA approves Akebia Therapeutics’ Vafseo for anemia in dialysis patients

In a significant development for the treatment of anemia related to chronic kidney disease (CKD) in dialysis patients, Akebia Therapeutics, Inc. (Nasdaq: AKBA), a pioneering biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) approval of Vafseo (vadadustat) Tablets. This approval marks a crucial milestone in providing an alternative and innovative treatment option for hundreds of thousands of Americans diagnosed with this condition. Vafseo, a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, stimulates the body’s natural response to hypoxia, enhancing the endogenous production of erythropoietin, thereby managing anemia effectively.

John P. Butler, Chief Executive Officer of Akebia, expressed the company’s dedication to kidney patients and highlighted the achievement, stating, “With the approval of Vafseo in the U.S., we’re proud to deliver an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anemia due to CKD.” This approval is grounded in the efficacy and safety data from the INNO2VATE program, along with a comprehensive assessment of post-marketing safety data from Japan, where VAFSEO was first launched in August 2020. The results from the INNO2VATE program have been prominently published in the New England Journal of Medicine.

Anemia in CKD patients on dialysis presents a significant healthcare challenge, affecting approximately 500,000 adult patients in the U.S. alone. The condition can lead to numerous adverse clinical outcomes, emphasizing the need for effective and manageable treatment options. Historically, the majority of CKD patients have been treated with injectable erythropoiesis-stimulating agents, primarily administered at dialysis centers. The approval of Vafseo introduces a promising oral alternative that could potentially set a new standard of care for adult dialysis patients.

The introduction of Vafseo has garnered widespread support from the medical community and patient advocacy groups. Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Division of Nephrology at Stanford University, underscored the benefit of having additional therapeutic options for maintaining hemoglobin concentrations within recommended target ranges. Furthermore, Lori Hartwell, Founder and President of the Renal Support Network, lauded the introduction of innovative treatment options for people battling anemia, highlighting the significant impact of the condition on patients’ daily lives.

Akebia Therapeutics plans to leverage its experienced commercial team and its partnership with CSL Vifor, a leader in bringing innovative therapies to U.S. dialysis organizations, to commercialize Vafseo in the United States. This strategy aims to position Vafseo as the new oral standard of care for adult dialysis patients, with a focus on enhancing patient outcomes and quality of life.

John P. Butler expressed his gratitude towards the patients, physicians, investigators, and site coordinators who participated in the clinical trials, emphasizing that this approval represents the culmination of years of dedicated effort by Akebia employees and partners to improve the lives of those affected by kidney disease.

The FDA approval of Vafseo represents a significant advancement in the treatment of anemia in CKD patients undergoing dialysis. By offering an oral treatment option, Vafseo has the potential to improve the quality of life for many patients and could lead to broader changes in how anemia associated with CKD is managed in the dialysis setting. As Vafseo becomes available in the U.S., healthcare providers and patients alike will be keenly watching its impact on treatment protocols and patient outcomes.