Posted by Michael Wonder on 24 Feb 2023
Akebia receives positive CHMP opinion in Europe for Vafseo (vadadustat) for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
23 February 2023 - Akebia Therapeutics today announced that the CHMP of the EMA has adopted a positive opinion recommending the European Commission to approve Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
The CHMP based its positive opinion on data from a comprehensive development program that included over 7,500 patients, including the global Phase 3 clinical program of vadadustat for the treatment of anaemia due to chronic kidney diseasw in adult patients on dialysis (INNO2VATE).
