Edoxaban Approved for AF, DVT/PE in Europe


June 26, 2015

TOKYO, JAPAN — The European Commission (EC) has given its stamp of approval to 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), according to the oral factor Xa inhibitor's developer and marketer[1]. The agency's decision, widely expected, follows a favorable recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2015, as reported then by heartwire from Medscape.

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.

The approvals are based on the randomized trials ENGAGE-TIMI 48, in nonvalvular AF, and Hokusai-VTE, in which the drug was used for prevention of recurrent VTE/PE.


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