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Akebia and Otsuka tweak design of late-stage vadadustat studies, marketing approval in Japan may be 2021; shares down 2% [Seeking Alpha]

AKEBIA THERAPEUTICS (AKBA)  More Company Research Source: Seeking Alpha
Last akebia therapeutics earnings: 5/9 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.akebia.com/investor-relations
PDF Akebia and Otsuka tweak design of late-stage vadadustat studies, marketing approval in Japan may be 2021; shares down 2%In anupdate to investors, Akebia Therapeutics (AKBA-1.6%) announces that it and commercialization partner Mitsubishi Tanabe Pharma have changed the designs of two Japan-based Phase 3 studies, FO2RWARD and TRILO2GY, evaluating vadadustat in patients with anemia associated with dialysis-dependent chronic kidney disease ((DD-CKD)).FO2RWARD will now include a broader dialysis population and larger sample size with once-daily and 3x/week dosing. It is designed to inform ESA (erythropoietin stimulating agent)-switching protocols. The study will be initiated next quarter with top-line data expected by year-end/early 2019.TRILO2GY will also include a larger sample size and once-daily and 3x/week dosing. It is designed to inform switching from Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Vifor Pharma'sMircera (methoxy PEG-epoetin beta). The study will laun [Read more]

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