Akebia Receives EC’s Marketing Authorisation of Vafseo (vadadustat) for the Treatment of Symptomatic Anaemia
Shots:
- 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
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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.
