Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for Anemia in CKD

 Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis, was complete. The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.

https://www.prnewswire.com/news-releases/akebia-receives-fda-acceptance-of-resubmission-to-nda-of-vadadustat-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-301967287.html