Posted by Michael Wonder on 30 Mar 2021
Akebia submits new drug application to the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
30 March 2021 - Akebia Therapeutics today announced that it has submitted a new drug application to the U.S. FDA for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anaemia due to chronic kidney disease in both adult patients on dialysis and adult patients not on dialysis.
Otsuka is working in close collaboration with Akebia to prepare a marketing authorisation application for vadadustat for submission to the EMA, expected this year.
