Akebia Therapeutics receives FDA approval for Vafseo (vadadustat) for dialysis patients

Akebia Therapeutics, Inc.

FDA approved Vafseo for anemia due to CKD in adults on dialysis ≥3 months; boxed warning for thrombosis risks.
Vafseo is a once-daily oral HIF-PH inhibitor; already approved in 37 countries.
~500,000 U.S. adult dialysis patients suffer from CKD anemia.
Approval based on INNO2VATE Phase 3 program data published in NEJM 2021; plus Japan post-marketing data.
Akebia plans U.S. launch with commercial team and CSL Vifor partnership; conference call March 28.

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