Vadadustat assigned PDUFA action date of March 29, 2022
The US Food and Drug Administration has accepted for filing the New Drug Application (NDA) for vadadustat in the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.
The drug is under development by US biotech Akebia Therapeutics (Nasdaq: AKBA) and Japan’s Otsuka Pharmaceutical (TYO: 4578).
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 it is not currently planning to hold an Advisory Committee meeting to discuss the application. The two companies, which agreed to collaborate on the development and commercialization of vadadustat in 2016, first submitted the NDA in March.
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