Data from the Non-interventional EMIT-AF/VTE Study Shows Low Thromboembolic and Bleeding Event Rates in Unselected Elder

Publicado 19/03/2019 10:30:48CET

More than 10 studies, more than 100,000 patients worldwideDaiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in AF and VTE designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in the edoxaban clinical research programme which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-interventional studies, including completed, ongoing and future research. The goal is to generate new clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.

The RCTs include:

-- ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), in AF patients at moderate-to-high risk of thromboembolic events -- Hokusai-VTE (Edoxaban in Venous Thromboembolism), in patients with either acute symptomatic DVT, PE or both -- 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 -- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan -- ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation) -- ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) - Atrial Fibrillation)

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 nonvalvular 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 -- ANAFIE (All Nippon AF In Elderly) Registry in Japan -- Cancer-VTE Registry in Japan

Through our Clinical Research Programme, 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.

For more information, please visit: https://www.daiichisankyo.com/rd/pipeline/products/ecrp/index.html [https://www.daiichisankyo.com/rd/pipeline/products/ecrp/index.html]

About Daiichi SankyoDaiichi 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 15,000 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: www.daiichisankyo.com [http://www.daiichisankyo.com/].

Forward-looking statementsThis 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. Steffel, J. et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-1393.

2. Colonna, P. et al. Periprocedural edoxaban management in routine clinical practice is associated with low bleeding risk: outcomes from the prospective multicentre, multinational EMIT-AF/VTE study. Abstract presented at EHRA 2019.

3. Clinicaltrials.gov. Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE). Available at https://clinicaltrials.gov/ct2/show/NCT02950168 [https://clinicaltrials.gov/ct2/show/NCT02950168]. Last accessed February 2019.

4. Colonna P, et al. Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE)--Trial design. Clin Cardiol. 2018; 41:1123-1129. https://doi.org/10.1002/clc.23037 [https://doi.org/10.1002/clc.23037]

5. National Heart, Lung and Blood Institute - What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html [http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html]. Last accessed February 2019.

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10. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) -- Blood Clot Forming in a Vein. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/ncbddd/dvt/facts.html [http://www.cdc.gov/ncbddd/dvt/facts.html]. Last accessed February 2019.

11. Van Beek E, et al. Deep vein thrombosis and pulmonary embolism. New York: John Wiley & Sons, 2009. Print.

12. Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost. 2007;98(4):756-764.

13. Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 suppl 1):I-22-30.

March 2019 Job Code: EDX/19/0093

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

Web site: http://www.daiichisankyo.com/

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