Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

RTTNews | 622 dias atrás
Stocktwits
Akebia Therapeutics Resubmits NDA For Vadadustat To FDA

(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is currently approved for use in 35 countries.

Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days. Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

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Akebia Therapeutics Expects To Resubmit NDA For Vadadustat NDA In Q3

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