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- Daiichi Sankyo announces enrollment of first patient in ETNA-AF-Europe and the commencement of ETNA-VTE-Europe, two regional registries to collect robust information on how once-daily LIXIANA(R) is being used in real world settings - ETNA is a Daiichi Sankyo global initiative which will collect data from approximately 30,000 patients taking edoxaban during a follow-up period of up to four years - LIXIANA(R) is an oral, once-daily, factor Xa-inhibitor, that is licensed in Europe for stroke prevention in NVAF and for the treatment and prevention of recurrent DVT and PE
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) announced that the first patient has been enrolled in ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice - Atrial Fibrillation - Europe), as well as the commencement of ETNA-VTE-Europe (Edoxaban Treatment in routiNe clinical prActice - Venous ThromboEmbolism - Europe).
The European ETNA registries are part of the global ETNA initiative which is comprised of regional patient registries designed to reflect regional needs and local clinical practice. The objective of ETNA is to collect a robust set of information on how once-daily LIXIANA(R) (edoxaban) is being used in real world settings. This will include safety and efficacy parameters as well as other important data that can help to guide best use of once-daily LIXIANA(R). In Europe, ETNA will be conducted across 12 countries and will collect data from up to 15,700 patients.
"ETNA will provide important information on how this new once-daily oral anticoagulant is being used in patients in real world settings," said Dr. Juan-Carlos Jaramillo, Head of Market Access and Medical Affairs at Daiichi Sankyo Europe GmbH. "Daiichi Sankyo is investing in the late phase programme for edoxaban to answer customer's question on the use of LIXIANA(R) (edoxaban), and ETNA is an exciting opportunity to provide further information enabling healthcare systems to make best use of this important medicine."
In Europe, the two non-interventional ETNA registries are being conducted in patients who are already receiving once-daily LIXIANA(R) for its licenced indications. In ETNA-AF-Europe, data from approximately 13,000 patients will be collected from 1,450 sites across 12 countries. In ETNA-VTE-Europe, data from approximately 2,700 patients will be collected from 660 sites, across 11 European countries.
In June 2015 the European Commission (EC) granted Marketing Authorisation for LIXIANA (R), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
In the ENGAGE AF-TIMI 48 study, once-daily LIXIANA(R) showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA(R) 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety and significantly reduced major bleeding (2.75% vs. 3.43% per year, LIXIANA(R) 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.
The Hokusai-VTE study demonstrated that once-daily LIXIANA(R) effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, LIXIANA(R) 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). Once-daily LIXIANA(R) also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).
ETNA-AF-Europe is a non-interventional post-authorization safety study (PASS). It will enroll 13,100 patients from 1,450 sites across 12 countries in Western Europe. The study will follow patients taking once-daily LIXIANA(R) for NVAF for up to four years. The primary objective of ETNA-AF-Europe is to collect real world safety data on bleeding events including intracranial hemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality in NVAF patients treated with once-daily LIXIANA(R). Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.
Secondary objectives include assessing the effect of once-daily LIXIANA(R) on patient relevant outcomes such as stroke, systemic embolic events, major CV events and hospitalizations related to CV condition. ETNA-AF-Europe will also collect real world data on a range of additional measures including Resource Utilization and Patient Reported Outcomes (PRO) data as well as useful elements such as the Montreal Cognitive Assessment (MoCA).
ETNA-VTE-Europe is a registry which will examine real world use of once-daily LIXIANA (R) in patients with acute VTE i.e. DVT and PE. The primary objective is the overall symptomatic VTE recurrence rate during an overall observational period of 18 months in unselected patients with acute VTE. The co-primary objective of this study is to collect real world safety data on bleeding events, other relevant drug related adverse events, and mortality (VTE-related and all-cause). Furthermore, safety analyses in pre-specified subpopulations such as patients with renal impairment and patients with hepatic impairment will be performed.
Secondary objectives include assessing the effect of once-daily LIXIANA(R) on patient relevant outcomes such as major CV events and hospitalizations related to CV condition.
ETNA-VTE-Europe will also collect real world data on a range of additional measures including Resource Utilization and PRO data as well as useful elements such as post-thrombotic syndrome (PTS).
About LIXIANA(R) (edoxaban)
Once-daily LIXIANA(R) was developed solely by Daiichi Sankyo. It received EU approval in June 2015 for the prevention of stroke and SE in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or TIA as well as for the treatment of DVT and PE, and prevention of recurrent DVT and PE in adults. It has launched in the United Kingdom and Germany with further European launches planned for 2015.
LIXIANA(R) was launched in Switzerland in May 2015 for the prevention of stroke and SE in adult patients with NVAF, and for the treatment of adult patients with VTE, including DVT and PE, following previous treatment with fractionated or unfractionated heparin for five days, as well as for the prevention of recurrent VTE. In addition, edoxaban is currently marketed in Japan and the United States.,, In other countries, regulatory review is ongoing.
About AF and VTE
AF, a heart rhythm disorder in which the heartbeat is rapid and irregular, affects over six million Europeans. People with AF are at a five-fold increased risk of stroke compared to the general population, with an estimated financial burden of over EUR38 billion a year. VTE, a condition where a blood clot forms in a vein, also represents a major cause of morbidity and mortality, resulting in over 500,000 deaths in the EU each year.
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 17,000 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 its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: http://www.daiichisankyo.com.
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(22):2093-104. 2) Büller H, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-15. 3) Daiichi Sankyo press release - Daiichi Sankyo's Once-Daily Lixiana(R) (edoxaban) Approved for the Prevention of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation and for the Treatment and Prevention of Recurrent Venous Thromboembolism in Switzerland. 15 April 2015. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006269.html [Last accessed: August 2015]. 4) Daiichi Sankyo press release - Daiichi Sankyo Receives Approval for Additional Indications of LIXIANA(R) (edoxaban) in Japan. 26 September 2014. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006189.html . [Last accessed: August 2015]. 5) Daiichi Sankyo press release - Daiichi Sankyo launches LIXIANA(R) (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: August 2015]. 6) Daiichi Sankyo press release - U.S. FDA Approves Daiichi Sankyo's Once-Daily SAVAYSA (TM) (edoxaban) Tablets for Reduction of Stroke Risk in Non-Valvular Atrial Fibrillation and for the Treatment of Venous Thromboembolism - 8 January 2015. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006236.html [Last accessed: August 2015]. 7) Camm A, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369-429. 8) Allender S, Scarborough P, Peto V, et al. European Cardiovascular Disease Statistics 2012 Edition. 9) Cohen AT, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;756-764: doi:10.1160/TH07.
Contact Lydia Worms (Europe) Daiichi Sankyo Europe GmbH Edoxaban Comm. & Product PR Europe +49(89)7808751 Yasuki Minobe (Global) Daiichi Sankyo Group Corporate Communications Department +81(3)62251126