LONDON, December 1, 2010 /PRNewswire/ -- Daiichi Sankyo
Company, Limited (TSE: 4568), announced today that it has
successfully completed patient enrollment for its phase III ENGAGE
AF-TIMI 48 clinical study of edoxaban, a direct, specific, oral
Factor Xa inhibitor that is being investigated in two different
dosing regimens given once-daily, to prevent the occurrence of
strokes and systemic embolic events (SEE) in patients with atrial
fibrillation (AF).
An estimated 4.5 million people in Europe, 2.2 million Americans, and more than
800,000 people in Japan suffer
from AF.[i],[ii],[iii] Due to the aging population, the number of
patients with AF worldwide is likely to increase 2.5 fold by the
year 2050.[iv]
The ENGAGE AF-TIMI 48 study began enrollment in November 2008. It is an event-driven, randomised,
double-blind, double-dummy, parallel group, multi-centre,
multi-national study designed to assess the efficacy and safety of
edoxaban compared to the current standard of care, warfarin.
Patients in the study are randomised to one of three treatment
groups: 30 mg edoxaban once-daily, 60 mg edoxaban once-daily, or
warfarin, a vitamin K antagonist treatment. In addition, edoxaban
doses are further adjusted to treat patients with renal impairment
and/or low body weight, or those taking strong P-glycoprotein
inhibitors. Those randomised to warfarin are dosed once-daily to
achieve an International Normalised Ratio (INR) between 2.0 and
3.0.
"The completion of enrollment for the largest AF outcomes study
ever undertaken -- ENGAGE AF-TIMI 48 --
marks a key milestone in the development of edoxaban and for
Daiichi Sankyo," said Glenn Gormley,
MD, PhD, Chief Science Officer & President, Daiichi Sankyo
Pharma Development.
This phase III global AF study, Effective aNticoaGulation with
factor xA next GEneration in Atrial Fibrillation (ENGAGE AF-TIMI
48), enrolled 21,107 subjects at nearly 1,400 clinical trial sites
located throughout North America,
South America, Africa, Asia,
Europe and Australia/New
Zealand. The primary endpoint of this study is to compare
the efficacy of edoxaban to warfarin in the prevention of stroke
and SEE. The primary safety assessment is the incidence of major
and clinically relevant non-major bleeding events.
"As new options to prevent stroke in AF patients become
available, it will be important that these treatments eliminate the
need for extensive monitoring and dietary modifications as well as
deliver a balanced benefit to risk profile," said Elliott Antman, MD, Professor of Medicine,
Harvard Medical School, Director,
Samuel A. Levine Cardiac Unit, Cardiovascular Division, Brigham and
Women's Hospital and Senior Investigator, TIMI Study Group, Global
Principal Investigator, ENGAGE AF-TIMI 48. "Based on phase II study
results, edoxaban has shown promise of potentially addressing the
needs of patients with AF and the physicians caring for them to
minimise the risk of embolic events."
About Atrial Fibrillation
Atrial fibrillation (AF) is an irregular heartbeat that is
caused when the upper chambers of the heart (the atria) do not beat
regularly and instead quiver erratically. When this happens, blood
may stagnate in the atria leading to blood clots. These blood clots
can break off and travel through the blood stream to the brain
where they can plug the blood vessels, causing a stroke. AF is the
most common type of clinically significant arrhythmia.[v]
Patients with AF have five times higher risk of having a stroke
than individuals without AF.[vi] These patients also tend to have
more serious first strokes than patients without AF, resulting in
higher mortality rates and longer hospital stays.[vii]
About Edoxaban
Edoxaban is a once-daily oral anticoagulant that directly
inhibits Factor Xa, an important factor in the coagulation process.
Edoxaban may offer physicians a wide therapeutic window to help
address patients' unique needs. Daiichi Sankyo is developing
edoxaban as a potential new treatment for the prevention of both
arterial and venous thromboembolism. Notably, Daiichi Sankyo has
more than 25 years experience conducting research in the area of
Factor Xa inhibition and was the first company to study these
compounds in humans. Edoxaban is being developed solely by Daiichi
Sankyo.
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 bacterial
infections, the Group is engaged in the development of treatments
for thrombotic disorders and focused on the discovery of novel
oncology and cardiovascular-metabolic therapies. Furthermore, the
Daiichi Sankyo Group has created a "Hybrid Business Model," which
will respond to market and customer diversity and optimise growth
opportunities across the value chain. For more information, please
visit http://www.daiichisankyo.com.
Daiichi Sankyo Europe, headquartered in Munich, Germany, is a member of the Daiichi
Sankyo Group. For more information on Daiichi Sankyo Europe, please
visit http://www.daiichi-sankyo.eu.
For more information, please contact:
Forward-Looking Statements
This news release may contain forward-looking statements based
on current assumptions and forecasts made by Daiichi Sankyo group.
Various known and unknown risks, uncertainties and other factors
could lead to material differences between the actual future
results, financial situation, development or performance of the
company and the estimates given here. These factors include those
discussed in our public reports, which are available on the website
at http://www.daiichisankyo-us.com. The company assumes no
liability whatsoever to update these forward-looking statements or
to conform them to future events or developments.
---------------------------------
[i] Fuster V et al. "ACC/AHA/ESC 2006 Guidelines for the
Management of Patients with Atrial Fibrillation - Executive
Summary," Circulation. 2006; 114:700-752.
[ii] American Heart Association. "Atrial Fibrillation,"
http://www.americanheart.org/presenter.jhtml?identifier=4451. Last
accessed November 24, 2010.
[iii] Inoue H et al. "Prevalence of Atrial Fibrillation in the
General Population of Japan: An
Analysis Based on Periodic Health Examination International,"
International Journal of Cardiology. 2009; 137:102-107.
[iv] Santini M, Ricci RP. "The Worldwide Social Burden of Atrial
Fibrillation: What Should Be Done and Where Do We Go," Journal of
Interventional Cardiac Electrophysiology. 2006; 17:183-188.
[v] National Heart Lung and Blood Institute. "What is Atrial
Fibrillation,"
http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Last
accessed November 24, 2010.
[vi] Hylek HM et al. "Effect of Intensity of Oral
Anticoagulation on Stroke Severity and Mortality in Atrial
Fibrillation," The New England Journal of Medicine. 2003;
349:1019-1026.
[vii] Jorgensen HS et al. "Acute Stroke with Atrial
Fibrillation," Stroke. 1996; 27:1765-1769.
Toshiaki Sai
Daiichi Sankyo Co., Ltd (Tokyo)
Phone: +81-3-6225-1126
Kimberly Wix
Daiichi Sankyo, Inc. (US)
Phone: +1-973-944-2338
Mobile: +1-908-656-5447
Dr. Michaela Paudler-Debus
Daiichi Sankyo Europe
Phone: +49-(0)89-7808-685
Mobile: +49-(0)172-845-8974
