The European Commission (EC) has approved edoxaban (Lixiana, Daiichi Sankyo) for high-risk patients with nonvalvular atrial fibrillation (AF) and for the treatment and prevention of deep-venous thrombosis (DVT) and pulmonary embolism (PE).
The indications specified in the EC approval, the company says, are prevention of stroke and systemic embolism in adult patients with nonvalvular AF “with one or more risk factors, such as congestive heart failure, hypertension, age ?75 years, diabetes mellitus, or prior stroke or transient ischemic attack” and “for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults.”
Known as Savaysa in North America, the novel oral anticoagulant (NOAC), which can be given once daily, was approved for essentially the same indications by the US Food and Drug Administration in January 2015.
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