Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

12 Sep 2024

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

Valadustat needed almost 15 years for to move from IND submission to NDA approval. • Source: Shutterstock

The US regulatory history of Akebia Therapeutics, Inc.’s Vafseo (vadadustat) featured a complete response letter, a denied formal dispute resolution request, and a race with two other drugs in the same novel class that were pursuing a broad indication for treatment of anemia in chronic kidney disease patients.

Ultimately, vadadustat earned the second CRL, and the second approval, of the three oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors...