Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis

John P. Butler, President and Chief Executive Officer of Akebia Therapeutics stated, “We are thrilled to be sharing positive top-line data from INNO2VATE, the first of our two global Phase 3 programs studying vadadustat to treat anemia due to CKD. It is extremely rewarding to see this program yield clear, consistent, straightforward results. We believe our data uniquely positions vadadustat as a potential new oral standard of care for treating all populations of dialysis patients, including both incident and prevalent dialysis patients, with anemia due to CKD, subject to approval.”

“We look forward to sharing these compelling data with regulators, as well as with physicians, dialysis providers and payers. We are more confident than ever that the clinical success we’ve demonstrated with INNO2VATE supports vadadustat’s potential for regulatory and commercial success, upon approval.” Butler continued, “The team is already at work on vadadustat’s New Drug Application (NDA), which we expect to file as quickly as possible following the top-line data readout of PRO2TECT, our global Phase 3 program studying vadadustat in adult patients not on dialysis with anemia due to CKD, which we expect in mid-2020, as planned. We believe that the INNO2VATE data will be highly informative for physicians, patients, dialysis providers and payers, as they make important decisions about patient care, once vadadustat is approved.”

Global Phase 3 INNO2VATE Program
Akebia’s global INNO2VATE program is a cardiovascular outcomes program that includes two separate Phase 3 studies (Correction/Conversion and Conversion), which collectively enrolled 3,923 adult patients on dialysis with anemia due to CKD. Both INNO2VATE studies are global, multicenter, open label (sponsor blinded), active-controlled (darbepoetin alfa – an injectable erythropoiesis stimulating agent (ESA)), non-inferiority studies. In both studies, patients were randomized 1:1 to receive either vadadustat or darbepoetin alfa. Vadadustat was initiated at a starting oral dose of 300 mg once daily and adjusted over time in increments of 150 mg within the range of 150 to 600 mg daily using a dose adjustment algorithm, while darbepoetin alfa was dosed per the US package insert (USPI) or summary of product characteristics (SmPCs) in appropriate geographies.

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