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Daiichi Sankyo's Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
Date:8/31/2013

duction in recurrent symptomatic VTE among patients with severe pulmonary embolism who were treated with edoxaban."

"We are excited about the results from the Hokusai-VTE study demonstrating that once-daily edoxaban may provide a new treatment option for a broad range of VTE patients. Daiichi Sankyo plans to submit New Drug Applications for edoxaban for VTE by the first quarter of 2014 in the U.S., Japan and Europe," said Glenn Gormley, MD, PhD, Global Head of Research and Development and Senior Executive Officer, Daiichi Sankyo. "Daiichi Sankyo is committed to continuing the global development of edoxaban and looks forward to the presentation of the results from the phase 3 ENGAGE AF-TIMI 48 study in patients with atrial fibrillation at the 2013 American Heart Association Scientific Sessions in November."

About Hokusai-VTE

Hokusai-VTE was a global, event-driven, randomized, double-blind, parallel-group phase 3 clinical study involving 8,292 patients in 439 clinical sites across 37 countries to evaluate once-daily edoxaban in patients with symptomatic DVT and/or PE.1

Patients were randomized to one of two different treatment groups. Both groups received open-label enoxaparin or unfractionated heparin for at least five days, and either warfarin or placebo (administered to edoxaban group), followed by double-blind edoxaban 60 mg (n=4,118) (edoxaban 30 mg for patients with renal impairment or low body weight or p-glycoprotein inhibitor use) or warfarin (n=4,122) for at least three months and up to a maximum of one year (duration of study treatment was determined by the investigator based on the patient's clinical features). Patients were followed for 12 months regardless of treatment duration to provide investigators with a better understanding of outcomes in clinical practice relative to an on-treatment analysis only.1

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SOURCE Daiichi Sankyo Company, Limited
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1. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
2. Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE
3. Daiichi Sankyo ha completato larruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il più ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
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