Positive CHMP opinion in Europe for Vafseo for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.-Akebia Therapeutics.
Akebia Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
The EC will review the CHMP recommendation and deliver a final decision in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.
The CHMP based its positive opinion on data from a comprehensive development program that included over 7,500 patients, including the global Phase III clinical program of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE).