Daiichi Sankyo receives EU approval for anticoagulant Lixiana

Daiichi Sankyo has announced that the European Commission has granted marketing authorisation to its novel oral anticoagulant Lixiana.

The drug has been approved for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism.

This once-daily selective factor Xa-inhibitor demonstrated its safety and efficacy in the ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest single comparative global trials of a novel oral anticoagulant in patients with nonvalvular atrial fibrillation or venous thromboembolism.

It has been shown to combine proven effectiveness and a significantly better bleeding profile than well-managed warfarin.

Dr Jan van Ruymbeke, chief executive officer of Daiichi Sankyo Europe, said: "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."