Akebia Receives EMA’s CHMP Positive Opinion of Vafseo (vadadustat) for Symptomatic Anaemia Associated with Chronic Kidney Disease
Shots:
•The EMA’s CHMP has adopted a positive opinion recommending approval of Vafseo (HIF-PH inhibitor) for symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. The EC’s decision is expected in ~2mos.
•The opinion was based on the comprehensive development program incl. the P-III (INNO2VATE) program of vadadustat. The trial met its primary & secondary efficacy EPs in each of 2 (INNO2VATE) studies i.e., (Correction/Conversion and Conversion) & showed non-inferiority to darbepoetin alfa
•The therapy also achieved primary safety EPs i.e., non-inferiority of vadadustat over darbepoetin alfa in time to 1st occurrence of major adverse cardiovascular EPs. The EC’s decision will valid for all 27 EU member states, Iceland, Norway & Liechtenstein
Ref: Akebia | Image: Akebia
Related:- Akebia Amended and Restated License Agreement with Vifor Pharma to Launch Vadadustat in the US
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
