Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2012.
As previously disclosed, an application for ELIQUIS for stroke prevention in atrial fibrillation has been validated for review by the European Medicines Agency.
The submissions were based on the results of the ARISTOTLE and AVERROES studies, two Phase 3 trials that evaluated the efficacy and safety of ELIQUIS for the prevention of stroke or systemic embolism in patients with atrial fibrillation. These two trials, which included approximately 24,000 patients, comprise the largest completed clinical development program for stroke prevention in atrial fibrillation among novel oral anticoagulants, and included patients eligible for anticoagulant therapy based on current treatment guidelines, as well as patients expected or demonstrated to be unsuitable for vitamin K antagonist (VKA) therapy.
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