Tokyo, April 6, 2010 (ots/PRNewswire) - Daiichi Sankyo Company, Limited
announced today that it has submitted a New Drug Application to the
Ministry of Health, Labor and Welfare in Japan seeking approval of
the anticoagulant, edoxaban, for the prevention of venous
thromboembolism (VTE) after major orthopedic surgery.
Edoxaban, being developed solely by Daiichi Sankyo, is an oral
anticoagulant that directly and specifically inhibits Factor Xa, a
clotting factor in the blood. Results from pivotal Phase III studies
showed that once-daily oral administration of edoxaban reduced the
incidence of VTE in patients undergoing total knee replacement or
total hip replacement, and the non-inferiority to injectable
enoxaparin sodium was confirmed.
"Upon approval, we believe that edoxaban, with its simple
once-daily oral dosing, will be a significant improvement for
patients undergoing orthopedic surgery in Japan," said Dr. Kazunori
Hirokawa, Head of the R&D Division of Daiichi Sankyo, Co., Ltd.
The pivotal Phase III studies conducted to support this first
application in Japan - one in knee surgery and the other in hip
surgery - were randomized, double-blind, parallel group, multi-center
trials comparing a once-daily, 30 mg oral dose of edoxaban to 2,000
IU (20 mg) twice-daily subcutaneous injections of enoxaparin sodium.
Treatment was provided for 11 to 14 days in both trials.
The primary efficacy endpoint in both trials was to confirm
non-inferiority of edoxaban to enoxaparin sodium for the prevention
of asymptomatic and symptomatic deep vein thrombosis and symptomatic
pulmonary embolism. The primary safety endpoint in both trials was to
compare the incidence of major and clinically relevant non-major
bleeding between edoxaban and enoxaparin sodium groups.
Full trial results will be submitted for presentation and
publication in peer-reviewed settings.
Global Development of Edoxaban
The global clinical development program for edoxaban includes
several indications, including the prevention of stroke and systemic
embolic events in patients with atrial fibrillation, as well as the
acute treatment and long-term secondary prevention of VTE.
"Early phase data show that edoxaban is an innovative
anticoagulant with direct, specific and reversible activity on Factor
Xa, which is being investigated as a treatment for a variety of
medical conditions, such as atrial fibrillation and VTE, as an
alternative to current oral and injectable products," said Dr.
@@start.t1@@ Global studies include:
- ENGAGE AF-TIMI 48: Investigating once-daily edoxaban versus warfarin in
more than 16,500 patients with atrial fibrillation for the prevention
of stroke and systemic embolic events. ENGAGE AF-TIMI 48 began
enrollment in late 2008.
- HOKUSAI VTE: To date, the largest single trial for the secondary
prevention of recurrent VTE in patients with deep vein thrombosis and
pulmonary embolism as well as for the acute treatment of VTE. HOKUSAI
VTE began enrollment in early 2010.@@end@@
Both HOKUSAI VTE and ENGAGE AF-TIMI 48 are Phase III,
multi-national, randomized, double-blind studies.
About Daiichi Sankyo
In keeping with its vision of becoming a "Global Pharma
Innovator," the Daiichi Sankyo Group is dedicated to the creation and
supply of innovative pharmaceutical products to address the
diversified, unmet medical needs of customers in both developed 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 optimize growth
opportunities across the value chain.
For more information, please visit http://www.daiichisankyo.com
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is
the U.S. subsidiary of Daiichi Sankyo Company, Ltd. For more
information on Daiichi Sankyo, Inc., please visit http://www.dsi.com.
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.
ots Originaltext: Daiichi Sankyo
Im Internet recherchierbar: http://www.presseportal.ch
CONTACT: For more information, please contact: Toshiaki Sai,
DaiichiSankyo, Co., Ltd.(Japan), +81-3-6225-1126 (office); Kimberly
Wix, DaiichiSankyo, Inc. (US), +1-973-944-2338 (office),
+1-908-656-5447 (mobile); Dr.Michaela Paudler-Debus, Daiichi Sankyo
Europe GmbH, +49(0)89-78-08-685(office), +49(0)172-845-8974 (mobile)