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
TOKYO, October 25, 2012
TOKYO, October 25, 2012 /PRNewswire/ --
Edoxaban is an investigational, once daily, novel oral factor Xa inhibitor
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced
that it has completed patient enrolment in the global Hokusai-VTE phase 3
study investigating the once-daily oral factor Xa inhibitor edoxaban for the
treatment and prevention of recurrence of venous thromboembolism (VTE) in
patients who have had an acute symptomatic deep vein thrombosis (DVT),
pulmonary embolism (PE), or both. ^[ ^1 ^] ^, ^[ ^2 ^] Hokusai-VTE is the
largest single phase 3 clinical study in the treatment and prevention of
recurrence of VTE. More than 8,250 patients have been enrolled in the trial
from more than 400 clinical sites across 38 countries worldwide. ^[ ^1 ^] ^,
^[ ^2 ^]
The Hokusai-VTE clinical study has been designed to reflect clinical practice,
using a standard heparin lead-in, and providing a flexible treatment duration
of three, six or 12 months. Edoxaban 60mg once-daily will be compared to
warfarin control therapy (target INR 2-3). ^[ ^2 ^] ^ This study design is
allowing investigators to evaluate patients with a broad range of risks,
including patients with moderate or severe conditions of PE and DVT. ^[ ^1 ^]
^, ^[ ^3 ^] ^, ^[ ^4]
"With its rigorous design and large patient population, Hokusai-VTE marks an
important step in the development of the new class of oral anticoagulants,
direct factor Xa inhibitors," said Professor Harry Büller, MD, PhD, Professor
of Internal Medicine, Chairman of the Department of Vascular Medicine at the
Academic Medical Center in Amsterdam, The Netherlands and Chairman of the
Hokusai-VTE steering committee. "What sets the Hokusai-VTE study apart from
other studies of its kind is that it aims to reflect clinical practice through
the flexible treatment duration."
Edoxaban is an investigational once-daily, novel oral anticoagulant that
specifically, reversibly and directly inhibits factor Xa, which is an
important factor in the coagulation system that leads to blood clotting. ^[ ^5
^] ^, ^[ ^6 ^]
"We are very pleased to announce that we have completed patient recruitment
for the Hokusai-VTE clinical study, the largest global study of its kind and
we expect to see first results during FY 2013," said Glenn Gormley, MD, PhD,
Global Head of Research and Development and Senior Executive Officer, Daiichi
The global edoxaban clinical trial program includes two phase 3 clinical
studies, Hokusai-VTE and ENGAGE AF-TIMI 48 ( E ffective a N ticoa G ulation
with Factor X A Next GE neration in A trial F ibrillation). ^[ ^1 ^] ^, ^[ ^7
The Hokusai-VTE clinical study is a double-blind, double-dummy, event-driven,
multi-national, randomized parallel-group phase 3 clinical study investigating
once-daily edoxaban in patients with symptomatic DVT and/or PE compared to
warfarin. ^[ ^1 ^] Hokusai-VTE is the largest single phase 3 clinical study in
the treatment and prevention of recurrence of VTE. More than 8,250 patients
have been enrolled in more than 400 clinical sites across 38 countries
worldwide. ^[ ^1 ^] ^, ^[ ^2 ^]
This study is named after the famous Japanese artist and painter Katsushika
About Venous Thromboembolism
VTE is the term for the generation of a blood clot within a vein, or the
subsequent breaking off of that clot into a pulmonary (lung) artery. ^[ ^8 ^]
DVT and PE are the two sub-types of VTE. ^[ ^3 ^] DVT is a blood clot found
anywhere in the deep veins of the legs, pelvis or arms. ^[ ^8 ^] PE occurs
when part of a clot from within a deep vein detaches and embolises to the
lungs lodging in the pulmonary arteries causing a potentially fatal condition.
^[ ^3 ^] ^, ^[ ^8 ^] PE is often accompanied by DVT and a DVT can develop into
a PE suddenly. ^[ ^3 ^] The ACCP Guidelines recommend that patients with
diagnosed VTE are treated for three, six or 12 months (and sometimes even
longer) based on the provoking factor and / or their individual risk profile
to prevent a second (recurrent) DVT or PE. ^[ ^3 ^] ^, ^[ ^4 ^]
VTE is a major cause of morbidity and mortality worldwide and the annual
incidence of VTE has been estimated at between one to three per 1000 with some
age and regional variation. ^[ ^9 ^] In Europe, more than 750,000 VTE events
affect people in six major European countries (France, Germany, Italy, Spain,
Sweden and UK) annually, and approximately 370,000 deaths are related to VTE
per year in these countries. ^[ ^10 ^] It is estimated that more than 900,000
fatal and non-fatal VTE events occur in the U.S. annually and approximately
300,000 deaths are related to VTE per year. ^[ ^11 ^] The prevalence of VTE is
predicted to double by 2050. ^[ ^12 ^] Thirty percent of people with VTE die
within one month of diagnosis and about 20% of those with PE experience sudden
death. ^[ ^13 ^]
Edoxaban is licensed only in Japan for the prevention of venous
thromboembolism (VTE) after major orthopaedic surgery, under the brand name
Lixiana ^® .
Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 of
clinical development and has not been approved yet. Daiichi Sankyo continues
to develop edoxaban at a global level as a potential new treatment for the
prevention of stroke and systemic embolic events (SEE) in patients with
non-valvular atrial fibrillation (AF) and for the treatment and prevention of
recurrence of VTE in patients with acute deep vein thrombosis (DVT) and/or
pulmonary embolism (PE).
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical products to address the diversified, unmet medical needs of
patients in both mature and emerging markets. While maintaining its portfolio
of marketed pharmaceuticals for hypertension, hyperlipidemia, and infectious
diseases, the Group is engaged in the development of innovative treatments for
thrombotic disorders and focused on the discovery of novel therapies in the
designated priority research areas of oncology and cardiovascular-metabolic
Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model,"
encompassing innovative pharmaceuticals (new drugs), established
pharmaceuticals (generics), vaccines, and OTC products, which will globally
respond to market and customer diversity and optimize growth opportunities
across the value chain. For more information, please visit:
This press release contains forward-looking statements and information about
future developments in the sector, and the legal and business conditions of
DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH.
Such forward-looking statements are uncertain and are subject at all times to
the risks of change, particularly to the usual risks faced by a global
pharmaceutical company, including the impact of the prices for products and
raw materials, medication safety, changes in exchange rates, government
regulations, employee relations, taxes, political instability and terrorism as
well as the results of independent demands and governmental inquiries that
affect the affairs of the company. All forward-looking statements contained in
this release hold true as of the date of publication. They do not represent
any guarantee of future performance. Actual events and developments could
differ materially from the forward-looking statements that are explicitly
expressed or implied in these statements. DAIICHI SANKYO, Co. Ltd, DAIICHI
SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no responsibility for the
updating of such forward-looking statements about future developments of the
sector, legal and business conditions and the company.
1. Daiichi Sankyo. Data on File.
2. Clinicaltrials.gov: NCT00986154. Comparative Investigation of Low Molecular
Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin
in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood
Clots.(The Edoxaban Hokusai-VTE Study). Available at:
http://clinicaltrials.gov/show/NCT00986154 . [Last accessed: July 2012].
3. Cleveland Clinic. Venous Thromboembolism. Available at:
. [Last accessed July 2012].
4. Guyatt, G et al. Executive Summary: Antithrombotic Therapy and Prevention
of Thrombosis, 9 ^th ed: American College of Chest Physicians Evidence-Based
Clinical Practice Guidelines. Chest . 2012;141:7S-47S.
5. Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy
Volunteers. J Clin Pharmacol . 2010;50:743-753.
6. Medscape Today News - Selective Factor Xa Inhibition: Coagulation Cascade.
Available at : http://www.medscape.com/viewarticle/456874_2 . [Last accessed:
7. Ruff, C et al. Evaluation of the novel factor Xa inhibitor Edoxaban
compared with warfarin in patients with atrial fibrillation: Design and
rationale for the Effective aNticoaGulation with factor xA next Generation in
Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 9ENGAGE
AF-TIMI 48). Am Heart J . 2010;160:635-641.
8. Loue S, Sajatovic M. Encyclopedia of Aging and Public Health. New York:
Springer, 2008.Terry PB. Lung Disorders 2007. Baltimore, MD: Johns Hopkins
9. Bramlage P, Pittrow D, Kirch,W. European Journal of Clinical Investigation,
2005; 35 (Suppl. 1):4-11.
10. Cohen A, Agnelli G, Anderson F. Venous thromboembolism (VTE) in Europe.
Thromb Haemost 2007; 98: 756-764.
11. Heit JA, Cohen AT, Anderson FAJ, on behalf of the VTE Impact Assessment
Group. Estimated annual number of incident and recurrent, non-fatal and fatal
venous thromboembolism (VTE) events in the US. ASH Annual Meeting Abstracts.
12. Deitelzweig S, Lin J, Johnson BH, Schulman KL. Prevalence of venous
thromboembolism in the USA: now and future. Thromb Haemost 2009;7 (Suppl.
2):207-8 (abstract OC-WE-018).
13. Heit JA. Venous thromboembolism epidemiology: implications for prevention
and management. Seminars in Thrombosis and Hemostasis . 2002;(s2):003- 014.
Contact: Contact: Michaela Paudler-Debus, PhD, Daiichi Sankyo, Co., Ltd.,
+81-36-2251338 (office); Lydia Worms, Daiichi Sankyo Europe GmbH,
+49-89-7808751 (office) ; Dr. Markus Schwertfeger, Daiichi Sankyo Europe GmbH,
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