Navigation Links
Daiichi Sankyo Submits Edoxaban Marketing Authorization Application to the EMA for Once-Daily Use for Stroke Prevention in Atrial Fibrillation and for the Treatment and Prevention of Recurrence of Venous Thromboembolism

TOKYO and MUNICH, Jan. 7, 2014 /PRNewswire/ -- Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application (MAA) for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency (EMA). In Europe, Daiichi Sankyo is seeking approval for edoxaban for the prevention 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 prevention of recurrence of symptomatic venous thromboembolism (VTE). If approved, edoxaban will be authorized for marketing in all European member states.

The MAA 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 submission of our MAA in Europe for edoxaban represents our long standing commitment to addressing the needs of patients living with cardiovascular diseases, including 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. "This milestone brings us one step closer to providing a new treatment option to patients living with AF or VTE, and we look forward to working with the EMA as it conducts its review of edoxaban."

Edoxaban is currently under regulatory review with the Japanese Ministry of Health, Labour and Welfare for NVAF and symptomatic VTE treatment.

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 MAA for edoxaban for the prevention of stroke and SEE in patients with NVAF, as well as for the treatment of DVT or PE and 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:

Michaela Paudler-Debus, PhD
Daiichi Sankyo Europe
+49 89 7808 685 (office)
+49 176 11780966 (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.


  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: [Last accessed: January 2014].

SOURCE Daiichi Sankyo
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Daiichi Sankyos Once-Daily Edoxaban Meets Primary Efficacy Endpoint for Stroke Prevention and Superiority for the Principal Safety Endpoint Compared to Warfarin for Patients with Atrial Fibrillation in a Phase 3 Clinical Trial
2. Daiichi Sankyos Once-Daily Edoxaban Shows Comparable Efficacy and Superiority for the Principal Safety Endpoint Compared to Warfarin in a Phase 3 Study for the Treatment of Symptomatic VTE and Prevention of its Recurrence
3. Daiichi Sankyo CEO John Gargiulo Elected as National Pharmaceutical Councils Chairman of the Board
4. Daiichi Sankyo ha completato larruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il più ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
5. Daiichi Sankyo Completes Enrolment in Hokusai - VTE, investigating once-daily Edoxaban in the Largest Single Phase 3 Study for the Treatment and Prevention of Recurrence of VTE
6. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
7. Orexigen Resubmits Contrave New Drug Application
8. Soligenix Submits NIAID Contract Proposal for Development of a Thermostable Ricin Vaccine
9. Omeros Submits OMS302 Marketing Authorization Application to European Medicines Agency
10. Omeros Submits New Drug Application to U.S. FDA for OMS302
11. Oramed Submits Pre-IND Meeting Request to FDA for its Oral Exenatide Capsule ORMD-0901
Post Your Comments:
(Date:11/26/2015)... 26 november 2015 AAIPharma Services ... geplande investering aan van ten minste $15,8 ... en het mondiale hoofdkantoor in ... resulteren in extra kantoorruimte en extra capaciteit ... groeiende behoeften van de farmaceutische en biotechnologische ...
(Date:11/26/2015)... 2015 Research and Markets ( ) has ... Market Outlook to 2019 - Rise in Cardiac Disorders and ... report to their offering. Boston ... scientific and others. --> The ... Boston scientific and others. ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
Breaking Medicine Technology:
(Date:11/29/2015)... Angeles, Ca (PRWEB) , ... November 29, 2015 , ... ... the American Board of Ophthalmology on November 25th 2015. Peer Certification by ... the field of his specialty. Certification in Ophthalmology is first obtained after the completion ...
(Date:11/29/2015)... ... 29, 2015 , ... Key Housing, a top-rated corporate housing service for the ... apartment community: Epic. In showcasing this featured apartment community in San Jose, Key Housing ... market to efficiently find housing suitable to their needs by showcasing quality housing. , ...
(Date:11/28/2015)... ... November 28, 2015 , ... Pixel Film Studios is back again with ... the possibilities are endless. Users have full control over angle of view, speed method, ... users are sure to get heads to turn. , ProPanel: Pulse offers fully customizable ...
(Date:11/27/2015)... ... ... The rapid speed at which Americans are aging is ... needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming more prevalent. Health ... of this equation: 80 percent of medical care occurs in the home, by ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with a ... component is distributed nationally, through a vast social media strategy and across a ...
Breaking Medicine News(10 mins):