Akebia Receives the MHRA’s Approval of Vafseo for Symptomatic Anemia Associated with Chronic Kidney Disease
Shots:
- The MHRA has granted marketing authorization for Vafseo (HIF-PH inhibitor) to treat symptomatic anemia associated with CKD in adults on chronic maintenance dialysis
- The approval was based on the results from a comprehensive development program for 7500 patients, incl. the P-III program (INNO2VATE) of vadadustat. In each of the two (INNO2VATE) studies, vadadustat met the primary & secondary efficacy EPs which showed non-inferiority to darbepoetin alfa as measured by a mean change in Hb b/w baseline, primary evaluation period (24-36wks.) & secondary evaluation period (40-52wks.)
- Vadadustat also achieved the primary safety EPs & showed non-inferiority of vadadustat in time to the first occurrence of major adverse cardiovascular events
Ref: PR Newswire | Image: Akebia
Related News:- Akebia Receives EC’s Marketing Authorisation of Vafseo (vadadustat) for the Treatment of Symptomatic Anaemia
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