Vafseo FDA Approval History
Last updated by Judith Stewart, BPharm on April 2, 2024.
FDA Approved: Yes (First approved March 27, 2024)
Brand name: Vafseo
Generic name: vadadustat
Dosage form: Tablets
Company: Akebia Therapeutics, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease
Vafseo (vadadustat) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
- Limitations of Use: Vafseo has not been shown to improve quality of life, fatigue, or patient well-being.
Vafseo is not indicated for use as a substitute for transfusion in patients requiring immediate correction of anemia, or in patients with anemia due to CKD not on dialysis. - Anemia is a common complication in people with CKD because their kidneys do not produce enough erythropoietin, a hormone that helps regulate the production of red blood cells.
- Vafseo works to treat anemia due to CKD by activating the physiologic response to hypoxia to stimulate the endogenous production of erythropoietin, which increases the production of hemoglobin and red blood cells.
- FDA approval of Vafseo was based on efficacy and safety data from the INNO2VATE program and an assessment of post marketing safety data from Japan where Vafseo was launched in August 2020.
- Vafseo is administered orally once daily, with or without food.
- Warnings and precautions associated with Vafseo include hepatotoxicity, hypertension, seizures, gastrointestinal erosion, and malignancy.
- Common adverse reactions include hypertension and diarrhea.
Development timeline for Vafseo
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
