Akebia resubmits New Drug Application to the FDA for vadadustat

Akebia has resubmitted its New Drug Application to the FDA for vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries. A letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.