Eliquis(R) (apixaban) Receives CHMP Positive Opinion for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE

June 27, 2014 11:05 AM

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Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted marketing authorization for the treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults. The CHMP's positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Eliquis for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland and Norway.

The positive opinion was based on the results from the pivotal AMPLIFY and AMPLIFY-EXT studies. AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY), a randomized, double-blind, multicenter trial, included 5,395 patients (2,691 were rando...

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