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 
TOKYO and PARSIPPANY, N.J., Jan. 8, 2014 /CNW/ - 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 
http://www.daiichisankyo.com 
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CO: Daiichi Sankyo Company, Limited
ST: New Jersey
NI: HEA MTC BTC  
-0- Jan/08/2014 17:30 GMT
 
 
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