Akebia expects to resubmit vadadustat NDA in Q3

Akebia expects to resubmit its New Drug Application – NDA – for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of Q3. Upon acceptance of the NDA, Akebia expects the FDA to set a PDUFA date of six months from the date of submission. Akebia received Meeting Minutes summarizing the discussion held during an End of Dispute Type A meeting with the FDA in July. The minutes reflect Akebia’s plan for the NDA resubmission discussed at the meeting. Vadadustat is currently approved for use in 34 countries.