Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3
(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday that the company 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 the third quarter of 2023.
Upon acceptance of the NDA, Akebia expects the U.S. Food and Drug Administration (FDA) to set a PDUFA date of six months from the date of submission.
Akebia received Meeting Minutes summarizing the productive and informative discussion held during an End of Dispute Type A meeting with the FDA in July 2023. The minutes reflect Akebia's plan for the NDA resubmission discussed at the meeting.
Vadadustat is currently approved for use in 34 countries.
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