FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

1. The U.S. Food and Drug Administration (FDA) has approved two oral medications for treating anemia related to chronic kidney disease (CKD).
- Vadadustat (brand name: Vafseo) is indicated for adult patients with CKD on dialysis for at least three months.
- Daprodustat (brand name: Jesduvroq) is approved specifically for adults with CKD who have been receiving dialysis for at least four months.

2. Both medications aim to address the issue of decreased erythropoietin production in CKD patients, which leads to anemia.

3. Vadadustat (Vafseo) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, while daprodustat (Jesduvroq) acts similarly, raising erythropoietin levels.

4. Vafseo was approved based on efficacy and safety data from the INNO 2VATE program, including post-marketing safety data from Japan.

5. Jesduvroq demonstrated effectiveness in a randomized study involving 2,964 adults on dialysis, maintaining hemoglobin levels within the target range of 10-11 grams/deciliter.

6. Both medications have a Black Box Warning for potential risks, including increased chances of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.

7. Vafseo will be commercialized in the U.S. through a partnership between Akebia Therapeutics and CSL Vifor, while Jesduvroq was approved by GlaxoSmithKline LLC.