← All approvals · Heart & blood · 2024
Vafseo (vadadustat)
The FDA approved Vafseo (vadadustat) on March 27, 2024 to treat anemia due to chronic kidney disease.
- Brand name
- Vafseo
- Generic name
- vadadustat
- FDA approval date
- March 27, 2024
- Approved use (FDA wording)
- To treat anemia due to chronic kidney disease
- Company
- Akebia
- Application
- NDA215192
- Dosage form / route
- TABLET · ORAL
- Drug class (EPC)
- Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Heart & blood
Indications and usage, from the FDA label
VAFSEO is 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 red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions ( 5.6 )] . VAFSEO 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 mo…