TOKYO, April 6, 2010 /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.
Hirokawa.
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.
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.
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, 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.
