COMUNICADO: CHMP Issues a Positive Opinion for Daiichi Sankyo's Once-Daily LIXIANA®▼ (edoxaban) in Patients with Atrial Fibrillation

 

COMUNICADO: CHMP Issues a Positive Opinion for Daiichi Sankyo's Once-Daily LIXIANA®▼ (edoxaban) in Patients with Atrial Fibrillation

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Publicado 17/07/2017 9:01:56CET

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

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.

Daiichi Sankyo Fights Thrombosis  

Daiichi Sankyo is your partner in antithrombotic therapy with the discovery and development of innovative products, to help patients with a wide range of cardiovascular conditions. These include EFIENT(R) (prasugrel) for acute coronary syndromes[10] and LIXIANA(R) (edoxaban) for non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism.[11] Daiichi Sankyo's ongoing commitment in this field is demonstrated by their continued investment into patient-relevant clinical development activities that aim to advance the care and improve the lives of people suffering with these diseases. For more information, please visit: http://www.daiichi-sankyo.eu.

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 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: 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/S0140-6736(16)31474-X. 2) National Heart, Lung, and Blood Institute. What is Cardioversion. 2012. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/crv /. [Last accessed: June 2017]. 3) Kirchhof P, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016;37:2893-2962. 4) January CT, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. J Am Coll Cardiol. 2014;64:e1-76. 5) Lip GYH, et al. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604. 6) 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: June 2017]. 7) Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485) :238-43. 8) 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. 9) Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824. 10) EFIENT Summary of Product Characteristics (SmPC), 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/ 000984/WC500021971.pdf [Last accessed: June 2017]. 11) LIXIANA. Summary of Product Characteristics (SmPC), 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/ 002629/WC500189045.pdf [Last accessed: June 2017].

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