Posted by Michael Wonder on 28 Sep 2023
Akebia Therapeutics resubmits new drug application to the FDA for vadadustat
28 September 2023 - Akebia Therapeutics today announced it has resubmitted its new drug application to the US FDA for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis.
Based on standard new drug application 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.
