Akebia completes End of Dispute Type A meeting with the FDA

Akebia Therapeutics completed an End of Dispute Type A meeting with the FDA to discuss Akebia’s forthcoming resubmission of its New Drug Application, or NDA, for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis. Akebia expects to receive the FDA’s meeting minutes by mid-August and plans to resubmit its NDA for vadadustat by the end of the third quarter of 2023. Upon acceptance of the NDA, Akebia expects the FDA to set a PDUFA date of six months from the date of submission.