Daiichi Sankyo Company, Limited today announced that the European Commission (EC) has granted marketing uthorisation for Lixiana (edoxaban), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (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.

“AF-related stroke as well as DVT and PE create a significant societal and economic health burden. We welcome the European Commission’s approval of Lixiana, which means physicians and patients may benefit from a new treatment option to effectively manage these debilitating and life-threatening conditions,” said Jan van Ruymbeke, MD, CEO, Daiichi Sankyo Europe GmbH. “Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. Once-daily Lixiana offers the unique combination of an easy-to-use oral anti-coagulant with proven efficacy across a broad range of patients and a better bleeding profile compared to well-managed warfarin.”

Atrial fibrillation (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 €38 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.

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