CAMBRIDGE, Mass., Dec. 1, 2021 /PRNewswire/ Akebia Therapeutics, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted 21. | December 1, 2021
Published: Jun 01, 2021
CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its collaborator,
U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.
The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. The FDA also indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.