Tous Actualités
Suivre
Abonner Daiichi Sankyo Europe GmbH

Daiichi Sankyo Europe GmbH

Edoxaban - next generation oral anticoagulant under investigation to help prevent stroke in patients with atrial fibrillation

Barcelona (ots)

New treatment could offer further option in addition to current 
standard of care in thromboembolic disease
Edoxaban, an oral factor Xa inhibitor, is currently being 
investigated in the pivotal phase III study ENGAGE AF-TIMI 48 
(Effective aNticoaGulation with factor xA next GEneration in Atrial 
Fibrillation) as a potential new treatment for stroke prevention in 
patients with atrial fibrillation (AF). The new drug, developed 
solely by DAIICHI SANKYO, could offer improvements in the management 
of thromboembolic disease.
In Europe, approximately 4.5 million people suffer from AF. 
"Without anticoagulation treatment these patients have a considerably
high risk of having a stroke, approximately five times higher than 
that of the average population" said John Camm, Professor of Clinical
Cardiology, St. George's University of London, UK, during a press 
conference organised by DAIICHI SANKYO EUROPE.
Anticoagulants interfere with the coagulation system resulting in 
a decreased tendency for the formation of blood clots, and are used 
to treat and prevent thromboembolic events. Existing anticoagulants, 
like heparin and vitamin K antagonists have been shown to be 
effective.1 However the use of these treatments, particularly vitamin
K antagonists, is limited by the requirement for close monitoring, 
drug-to-drug and food-to-drug interactions, as well as a considerable
risk of bleeding.(1)
"There is a definite need for new and improved oral anticoagulants
for stroke prevention in patients with atrial fibrillation", 
commented Jeffrey I. Weitz, MD, FACP, FRCP, Professor of Medicine and
Biochemistry, McMaster University and Director of the Henderson 
Research Centre, Ontario, Canada. "Edoxaban could offer significant 
improvements in the management of these patients."
A comprehensive phase I and phase II study programme for edoxaban 
has already indicated dose-dependent anticoagulation over a range of 
doses, with no significant dose-related increase in bleeding:
  • Edoxaban has a safety and tolerability profile similar to that of warfarin in patients with non-valvular atrial fibrillation.(2) The incidence of major and clinically relevant non-major bleeding events reported in the 30 mg and 60 mg once daily edoxaban treatment groups was similar to, or better than, those in the warfarin treated group. These doses of edoxaban are being compared with warfarin in the ongoing ENGAGE AF-TIMI 48 trial.
  • Edoxaban demonstrated significant dose-dependent reductions in venous thromboembolism after total knee or hip replacement surgery.(3,4)
These data are encouraging for patients and support edoxaban's 
potential to significantly streamline anticoagulation management, 
while providing effective protection against severe thromboembolic 
events like stroke. Results from the phase II studies are important 
because they have been used to establish the optimal dosing regimen 
to pursue in the phase III clinical trial ENGAGE AF-TIMI 48.
Experts are anticipating the outcome of this phase III study. 
"This study is intended to show that atrial fibrillation patients can
be treated simply, effectively and safely with once-daily 
administration of the factor Xa inhibitor edoxaban" said Robert 
Giugliano, MD, SM, FACC, Senior Investigator, TIMI-Study Group, 
Associate Physician and Assistant Professor in Medicine, Brigham and 
Women's Hospital, Harvard Medical School, Boston, USA.
ENGAGE AF-TIMI 48 compares two different doses of edoxaban with 
warfarin in patients with AF. Approximately 16,500 patients will be 
enrolled in this double-blind trial from 1,400 clinical sites 
worldwide. Patients will be assigned, in a double-blind, double-dummy
fashion, to one of three treatment groups: 30 mg edoxaban once daily,
60 mg edoxaban once daily or warfarin. Edoxaban will be given in 
fixed doses without coagulation monitoring. In contrast, the dose of 
warfarin will be adjusted to maintain the international normalised 
ratio (INR) between 2.0 and 3.0. The primary efficacy endpoint is 
stroke and systemic events, while the primary safety endpoint is the 
occurrence of major and clinically relevant non-major bleeding 
events, using the sensitive ISTH (International Society on Thrombosis
and Haemostasis) scale. The expected median treatment duration in the
study is 24 months; the sponsor, DAIICHI SANKYO, expects the study to
conclude in the first half of 2012.
Notes to editors:
  • Phase III trials will also be conducted to assess edoxaban for the prevention of venous thromboembolism (VTE) after hip or knee replacement surgery in Asian markets.
  • Factor Xa is a key enzyme in blood coagulation. When factor Xa is inhibited, blood clot formation is attenuated, thereby minimising the possibility of thromboembolic events, like stroke.
About DAIICHI SANKYO
DAIICHI SANKYO is a global pharmaceutical company that focuses on 
researching and marketing innovative medications. The company was 
created in 2005 through the merger of two traditional Japanese 
enterprises, Daiichi and Sankyo. With net sales of nearly 5.9 billion
? in fiscal year 2008, DAIICHI SANKYO is one of the world's 20 
leading pharmaceutical companies. The company's world headquarters is
in Tokyo, and its European base is located in Munich. DAIICHI SANKYO 
has affiliates in 12 European countries and has been one of the 
strongest Japanese pharmaceutical companies located in Europe since 
it set up European production facilities and marketing offices in 
1990. The company's research activities focus on the areas of 
cardiovascular diseases, haematology, diabetes, anti-infectives and 
cancer. Its aim is to develop medications that are "best" in their 
class or to create new classes of pharmaceutical drugs.  
http://www.daiichi-sankyo.eu
References:
(1). Weitz JI, Bates SM. New anticoagulants. J Thromb Haemost. 
2005; 3: 1843-53.
(2). Weitz JI, Connolly SJ, Kunitada S, Jin J, Patel I. 
Randomised, parallel group, multicentre, multinational study 
evaluating safety of DU-176b compared with warfarin in subjects with 
non-valvular atrial fibrillation. ASH Annual Meeting 2008; 112: 
Abstract 33.
(3). Fuji T, Fujita S, Tachibana S, Kawai Y.  Randomised, double 
blind, multi-dose efficacy, safety and biomarker study of the oral 
factor Xa inhibitor DU-176b compared with placebo for prevention of 
venous thromboembolism in patients after total knee arthroplasty. ASH
Annual Meeting 2008; 112: Abstract 34.
(4). Raskob G, Cohen A, Eriksson B et al.  Randomised, double 
blind, multi dose trial of the oral factor Xa inhibitor DU-176b 
versus LMW heparin (Dalteparin) for prevention of venous 
thromboembolism after total hip replacement. European Heart Journal. 
2008; 29: Abstract supplement 609.
Forward-looking statements
This press release contains forward-looking statements and 
information about future developments in the sector, and the legal 
and business conditions of 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 
EUROPE GmbH assumes no responsibility for the updating of such 
forward-looking statements about future developments of the sector, 
legal and business conditions and the company.

Contact:

Dr. Michaela Paudler-Debus
Head of Product PR
Corporate Communications and Public Affairs
DAIICHI SANKYO EUROPE GmbH
+ 49 89 7808 685 (direct)
+ 49 172 845 8974 (mobile)
michaela.paudler-debus@daiichi-sankyo.eu

Medical contact:

Dr. Felix Münzel
Vice Director Medical & Scientific Affairs CV
DAIICHI SANKYO EUROPE GmbH
+ 49 89 7808 0
felix.muenzel@daiichi-sankyo.eu

Plus de actualités: Daiichi Sankyo Europe GmbH
Plus de actualités: Daiichi Sankyo Europe GmbH