ENSURE-AF Data Support the Efficacy and Safety Profile of Daiichi Sankyo's Once-Daily LIXIANA®▼ (edoxaban) i

AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.[4] More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.[5],[6] Compared to those without AF, people with the arrhythmia have a three to five times higher risk of stroke.[7] One in five of all strokes are as a result of AF.[5]

About Edoxaban 

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting.

Extensive Clinical Research Program for Edoxaban 

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The extensive edoxaban research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research program, including completed, ongoing and future research.

The RCTs include:

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial
Fibrillation), in AF patients undergoing electrical cardioversion;
- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in
AF patients undergoing percutaneous coronary intervention;
- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in
patients with cancer and an acute VTE event.

In addition, global and regional registry studies will provide important real-world-data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with non
valvular Atrial Fibrillation);
- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous
ThromboEmbolism);
- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE);
- Prolongation PREFER in AF (PREvention oF thromboembolic events - European Registry) in
patients with AF.

We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

About Daiichi Sankyo  

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: http://www.daiichisankyo.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. 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.

 
Contact 
Lydia Worms (Europe) 
Daiichi Sankyo Europe GmbH 
Edoxaban Communications & Product PR Europe 
+49-(89)-7808751 

  References 

1) Goette, A, et al. Edoxaban versus enoxaparin / warfarin in subjects undergoing
cardioversion of atrial fibrillation: the randomized (ENSURE-AF) study. The Lancet.
Published online August 30, 2016: http://dx.doi.org/10.1016/.
2) Goette A, et al. Edoxaban versus enoxaparin/warfarin in subjects undergoing
cardioversion of atrial fibrillation: the randomized (ENSURE-AF) study. Presented at
the European Society of Cardiology. August 30, 2016. Rome, Italy.
3) National Heart, Lung and Blood Institute - What is Atrial Fibrillation. Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html. [Last accessed:
March 2016].
4) Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485)
:238-43.
5) Camm A, et al. ESC Guidelines for the management of atrial fibrillation: the Task
Force for the Management of Atrial Fibrillation. Eur Heart J. 2010;31(19):2369-2429.
6) Krijthe BP, et al. Projections on the number of individuals with atrial fibrillation
in the European Union, from 2000 to 2060. Eur Heart J. 2013;34(35):2746-2751.
7) Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the
21st century. Int J Card. 2013;167:1807-1824.