Akebia abandons Vafseo broad label pursuit for non-dialysis CKD after FDA alignment failure

Akebia Therapeutics, Inc.

Akebia will not initiate the VALOR trial for vadadustat in late-stage CKD not on dialysis after FDA feedback.
FDA indicated the trial would require significantly more patients and meaningfully more time and cost.
Akebia does not expect to pursue a broad label for Vafseo for non-dialysis dependent CKD patients.
Vafseo remains approved only for anemia in dialysis-dependent CKD patients; launched in U.S. Jan 2025.
Akebia is encouraged by FDA discussion on smaller subgroups but no specific path forward yet.

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