The approval was based on the results from a comprehensive development program of ~7,500 patients, incl. the P-III (INNO2VATE) program of vadadustat (HIF-PH inhibitor) for the treatment of anemia due to CKD in adult patients on dialysis
In each of the two (INNO2VATE) studies, vadadustat met the primary & secondary efficacy EPs which was found to be non-inferior to darbepoetin alfa as measured by a mean change in Hb b/w baseline & primary evaluation period (24-36wk.) and secondary evaluation period (40-52wk.)
The therapy also achieved the primary safety EPs & was non-inferior to darbepoetin alfa in time to 1st occurrence of major adverse cardiovascular EPs. The approval is valid for all 27 EU member states, Iceland, Norway & Liechtenstein
Ref: PR Newswire | Image: Akebia
Related News:- Akebia Receives EMA’s CHMP Positive Opinion of Vafseo (vadadustat) for Symptomatic Anaemia Associated with Chronic Kidney Disease
