5 minute read
Apr. 1, 2024

After Another Look, Vadadustat (VAFSEO) Becomes the Second HIF-PHD Inhibitor Approved by the FDA

vadadustat (VAFSEO)

oral HIF-PHD enzyme inhibitor Ph. III candidate for anemia in CKD carboxylic acid class of HIF-PHD inhibitors J. Pharmacol. Exp. Ther., Oct 1, 2022 Akebia Therapeutics, Cambridge, MA

Vadadustat (Vafseo) from Akebia Therapeutics is an oral hypoxia-inducible factor prolyl-4-hydroxylase domain (HIF-PHD) inhibitor developed for anemia in patients with chronic kidney disease (CKD). It received FDA approval on March 27th, 2024 for patients on dialysis for at least three months, after regulatory challenges including an earlier complete response letter due to safety concerns. This makes vadadustat the second FDA-approved HIF-PHD inhibitor for the treatment of anemia in CKD for dialysis-dependent patients after GSK’s daprodustat’s approval in Feb. 2023. To learn more about vadadustat, the unconventional regulatory path it has taken to approval, and where it sits in the competitive landscape of other HIF-PHD inhibitors, check out this article! 



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