EMA Recommends EU Marketing of Edoxaban in Atrial Fibrillation

Patrice Wendling

February 24, 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorization for edoxaban (Roteas, Daiichi Sankyo Europe) for prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors and for the treatment and prevention of deep vein thrombosis and pulmonary embolism[1].

Risk factors can include congestive heart failure, hypertension, age >75 years, diabetes mellitus, and prior stroke or transient ischemic attack.

Roteas, an oral direct factor Xa inhibitor, will be available as 15-, 30-, and 60-mg tablets. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time, and reduces the risk of thrombus formation.

The application for Roteas was an informed-consent application, which makes use of data from the dossier of a previously authorized medicine. The reference product for Roteas is Lixiana, according to the February 23, 2017 decision.

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