Akebia Plans 3rd Quarter Vadadustat NDA Resubmission

Akebia Therapeutics says it expects to resubmit an NDA to FDA in the third quarter for its vadadustat to treat anemia due to chronic kidney disease in patients on dialysis. The company says the resubmission follows its receipt of minutes summarizing an End of Dispute Type A meeting with FDA that discussed the NDA resubmission.

A 3/22 complete response letter cited concerns about an increased risk of thromboembolic events driven by vascular access thrombosis. It also expressed a concern about the risk of drug-induced liver injury and concern that ongoing monitoring would be less uniformly implemented once commercially available.

The meeting with FDA followed the agency’s denial of Akebia’s dispute resolution request.

Vadadustat is described as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. It is not approved by FDA.