Apixaban Approved in Europe for DVT, PE

July 29, 2014

PRINCETON, NJ and NEW YORK — Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), an oral factor Xa inhibitor, is now approved in Europe for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the recurrence of DVT and PE[1].

The European Commission approved apixaban following a "positive opinion" from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion was based on its review of the AMPLIFY trial and AMPLIFY-EXT , an extension study.

In AMPLIFY, a study of 5395 patients with acute, symptomatic VTE and/or PE reported by heartwire , apixaban was as effective as standard therapy with enoxaparin plus warfarin for the treatment of venous thromboembolism (VTE). Treatment with apixaban also significantly reduced the risk of bleeding. In the extension study, anticoagulation with apixaban significantly reduced the risk of recurrent VTE compared with placebo.

The approval by the European Commission applies to all countries within the European Union as well as Iceland and Norway. Apixaban is currently approved in Europe for stroke and systemic embolism prevention in adults with nonvalvular atrial fibrillation and one or more risk factors. It is also approved for the prevention of VTE among patients who have undergoing hip- or knee-replacement surgery.

Other oral anticoagulants, including rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals) and dabigatran (Pradaxa, Boehringer Ingelheim), are also approved for the treatment of DVT/PE and prevention of DVT/PE recurrence.


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