MUNICH, January 22, 2016 /PRNewswire/ --
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced that the German public health agency, The Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA), has granted an indication of a minor additional benefit for LIXIANA® (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF). These findings will help to form the basis for the continued reimbursement for LIXIANA® by statutory health insurance providers in Germany. This recognition has been awarded due to improved patient outcomes, noting fewer bleedings including intracranial hemorrhages and major adverse events following treatment with edoxaban compared to warfarin. LIXIANA® is the first once-daily novel oral anticoagulant (NOAC), for which the G-BA has recognised an additional benefit.
Oliver Appelhans, Daiichi Sankyo Vice President and European Launch Leader, commented, "The Federal Joint Committee's decision reinforces the value of edoxaban for this at-risk patient population, and is further evidence of the solid clinical foundations upon which the treatment has been approved in countries throughout Europe." He continued, "Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. We're excited that edoxaban is now widely available in Europe and that regulators have consistently recognised its value as a treatment option."
The latest Federal Joint Committee follows full approvals granted by regulators in Scotland, the UK, Switzerland and The Netherlands for indications in prevention of stroke and SE in NVAF.
The Federal Joint Committee's decision is based on data from a large scale Phase III clinical study, ENGAGE AF-TIMI 48, which compared treatment with once-daily edoxaban to warfarin. This study represents one of the largest single comparative trials of a novel oral anticoagulant in this patient population, involving 21,105 patients. In this study, once-daily edoxaban 60 mg demonstrated non-inferiority to warfarin, for the primary efficacy endpoint of occurrence of stroke or SE in patients with NVAF (1.18% vs. 1.50% per year, respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001 for non-inferiority). In addition, once-daily edoxaban 60 mg demonstrated a significant 20% risk reduction of major bleeding in patients with NVAF compared to warfarin (2.75% vs. 3.43% per year, respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001).
AF a heart rhythm disorder in which the heartbeat is rapid and irregular, affects over six million people across Europe. People with AF are at a five-fold increased risk of stroke compared to the general population, with an estimated financial burden of over €38 billion a year.
After reviewing the available evidence, The Federal Joint Committee has indicated no additional benefit in its appraisal of edoxaban for the prevention of VTE. Oliver Appelhans commented, "We remain committed to the use of edoxaban for the prevention of VTE, as supported by the results of the pivotal Hokusai-VTE trial, which demonstrated a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin."
About The Federal Joint Committee
The Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The Federal Joint Committee assesses any additional benefit claimed by newly authorised pharmaceutical products over the appropriate comparator within six months of the product launch. Since 2011, G-BA findings have formed the basis for price negotiations between statutory health insurance providers and the pharmaceutical industry for new active ingredients.
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.
Edoxaban 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 ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic 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. Edoxaban is currently marketed in the UK, Germany, Switzerland, the US and Japan. In other countries, regulatory review is ongoing.
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.daiichi-sankyo.eu.
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.
- Gemeinsamer Bundesausschuss - G-BA. Tragende Gründe. zum Beschluss des Gemeinsamen Bundesausschusses über eine Änderung der Arzneimittel-Richtlinie (AM-RL): Anlage XII - Beschlüsse über die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a SGB V - Edoxaban. January 2016.
- SMC Advice Directory. Edoxaban (LIXIANA). Available at: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1095_15_edoxaban_Lixiana_NVAF/edoxaban_Lixiana_NVAF. (Last accessed January 2016).
- Daiichi Sankyo press release - UK's NICE recommends once-daily LIXIANA® (edoxaban) for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation. 24 September 2015. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006354.html. (Last accessed January 2016).
- Daiichi Sankyo press release - Daiichi Sankyo's Once-Daily Lixiana® (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 January 2016).
- Zorginstituut Nederland. GVS-rapport 15/12 edoxaban (Lixiana®) bij atriumfibrilleren. 8 September 2015.
- Giugliano R, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
- 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.
- Allender S, Scarborough P, Peto V, et al. European Cardiovascular Disease Statistics 2012 Edition.
EDX 16 0026 January 2016
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
SOURCE Daiichi Sankyo Company, Limited