EU approves Lixiana (edoxaban) for stroke prevention in patients with NVAF, and for DVT and PE- Daiichi Sankyo

The European Commission (EC) has granted Marketing Authorisation for Lixiana (edoxaban), from Daiichi Sankyo, a once a day selective Factor Xa inhibitor for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age over 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.

The EC approval is based on two Phase III clinical trials, ENGAGE AF-TIMI 48 and Hokusai-VTE, which compared treatment with once-daily Lixiana to warfarin, a current standard of care for stroke prevention in patients with AF or for the treatment and prevention of VTE. These studies represent the largest single comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.

Comment: Lixiana was shown in clinical trials to have comparable efficacy to warfarin but with a better safety profile and showed a reduced risk of bleeding- 2.7% versus 3.43 % with warfarin per year in the stroke prevention group.