Akebia completes FDA Type A meeting; expects to resubmit vadadustat NDA by Q3 2023

Akebia Therapeutics, Inc.

Completed End of Dispute Type A meeting with FDA to align on NDA resubmission for vadadustat for anemia due to CKD in dialysis patients.
Expects to receive FDA meeting minutes by mid-August 2023; resubmission planned by end of third quarter 2023.
Upon NDA acceptance, expects PDUFA date six months from submission; vadadustat is approved in 34 countries including recent Swissmedic approval.

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