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Bristol-Myers Squibb Co And Pfizer Inc Receives FDA Approves ELIQUIS (apixaban) To Reduce Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

Wednesday, 2 Jan 2013 08:00am EST 

Bristol-Myers Squibb Co and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Atrial fibrillation, the most common type of irregular heartbeat, affects approximately 5.8 million people in the U.S., and results in a five times greater risk of stroke. In the U.S., 15% of strokes are attributable to atrial fibrillation. The ELIQUIS clinical trial program is the completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients; it included two Phase 3 studies ARISTOTLE and AVERROES in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE evaluated ELIQUIS versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and AVERROES evaluated ELIQUIS versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin. The Full Prescribing Information for ELIQUIS includes a Boxed Warning for patients who discontinue treatment. Patients on ELIQUIS who discontinue treatment are at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. 

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