Posted by Michael Wonder on 15 Nov 2016
Once-daily anticoagulant Lixiana (edoxaban tosylate) approved in Canada for stroke prevention in atrial fibrillation and for the treatment and prevention of recurrent deep-vein thrombosis and pulmonary embolism
9 November 2016 - Servier Canada announced today that Lixiana (edoxaban tosylate) has been approved by Health Canada for the two following indications: prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), in whom anticoagulation is appropriate and for treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE.
The approval of Lixiana is based on data from two phase 3 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 and longest clinical development of a novel oral anticoagulant (NOAC) in patients with NVAF or VTE, involving 21,105 and 8,292 patients, respectively.
