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Daiichi Sankyo Submits SAVAYSA™ (edoxaban) Tablets New Drug Application to the U.S. FDA for Once-Daily Use for Stroke Risk



Daiichi Sankyo Submits SAVAYSA™ (edoxaban) Tablets New Drug Application to the
 U.S. FDA for Once-Daily Use for Stroke Risk Reduction in Atrial Fibrillation
 and for the Treatment and Prevention of Recurrence of Venous Thromboembolism

Submission based on the two largest comparative phase 3 clinical trials of a
novel oral anticoagulant in patients with non-valvular atrial fibrillation or
symptomatic venous thromboembolism

PR Newswire

TOKYO and PARSIPPANY, N.J., Jan. 8, 2014

TOKYO and PARSIPPANY, N.J., Jan. 8, 2014 /PRNewswire/ -- Daiichi Sankyo
Company, Limited (hereafter, Daiichi Sankyo) today announced that the New Drug
Application (NDA) for its investigational, oral, once-daily direct factor
Xa-inhibitor SAVAYSA™ (edoxaban) Tablets has been submitted to the U.S. Food
and Drug Administration (FDA). In the U.S., Daiichi Sankyo is seeking approval
for edoxaban for the reduction in risk of stroke and systemic embolic events
(SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for
the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for
the prevention of recurrence of symptomatic venous thromboembolism (VTE).
SAVAYSA is the proposed brand name for edoxaban if approved for marketing in
the U.S.

The NDA submission is based on data from an extensive global clinical trial
program that compared treatment with once-daily edoxaban to warfarin, a
current standard of care for patients with atrial fibrillation (AF) or VTE.
The two clinical trials that formed the basis of the submission, ENGAGE
AF-TIMI 48 and Hokusai-VTE, are the largest comparative trials of a novel oral
anticoagulant in these patient populations, involving 21,105 and 8,292
patients, respectively.^1,2

"The NDA submission in the U.S. is an important milestone in the development
of edoxaban and reflects our long-standing commitment to addressing the needs
of patients living with cardiovascular diseases, including those living with
AF or VTE," said Glenn Gormley, MD, PhD, Senior Executive Officer and Global
Head of Research and Development, Daiichi Sankyo Co., Ltd. and President and
CEO of Daiichi Sankyo, Inc. in the United States. "If approved, edoxaban may
provide a new treatment option for physicians and their patients with these
diseases. We look forward to working with the FDA as it conducts its review of
edoxaban."

About Edoxaban
Edoxaban is an investigational, oral, once-daily anticoagulant that
specifically inhibits factor Xa, which is an important factor in the
coagulation system that leads to blood clotting.^3 The global edoxaban
clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and
ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in
Atrial Fibrillation). The results from these trials form the basis of the NDA
for edoxaban for the prevention of stroke and SEE in patients with NVAF, as
well as for the treatment of DVT or PE and for prevention of recurrence of
symptomatic VTE.

Edoxaban is currently approved only in Japan, since April 2011, for the
prevention of VTE after major orthopaedic surgery, and was launched in July
2011 under the brand name LIXIANA^®. Elsewhere, including Europe and the U.S.,
edoxaban is currently in phase 3 clinical development and has not been
approved in any indication.^4

About Daiichi Sankyo 
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 optimize growth opportunities across the value chain. For more
information, please visit: www.daiichisankyo.com.

Contact
Alyssa Dargento
Daiichi Sankyo, Inc. 
adargento@dsi.com 
+1 973 944 2913 (office) 
+1 973 727 1604 (mobile) 

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. 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. assume no responsibility for the updating of such forward-looking
statements about future developments of the sector, legal and business
conditions and the company.

References

 1. Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial
    Fibrillation. N Engl J Med 2013;369:2093-2104. 
 2. Buller, H et al. Edoxaban versus Warfarin for the Treatment of Symptomatic
    Venous Thromboembolism. N Engl J Med  2013;369:1406-1415. 
 3. 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.
 4. Daiichi Sankyo press release - Daiichi Sankyo Launches LIXIANA^®
    (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention
    of Venous Thromboembolism after Major Orthopaedic Surgery. 19 July 2011.
    Available at:
    http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html.
    [Last accessed: January 2014].

 

SOURCE Daiichi Sankyo Company, Limited

Website: http://www.daiichisankyo.com
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