(By Balachander) Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) said ELIQUIS (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) has been approved by Japan health regulators.
The approval in Japan marks the third regulatory approval for ELIQUIS within six weeks, following approvals in the European Union and Canada, the companies noted.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb.
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According to the companies, ELIQUIS is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class.
Atrial fibrillation is the most common cardiac arrhythmia, a condition of irregular heart beat, which is responsible for roughly 20 percent of all strokes in Japan.
The companies said the approval of ELIQUIS in Japan is supported by the pivotal Phase 3 trial, ARISTOTLE, which evaluated the safety and efficacy of ELIQUIS versus warfarin in 18,201 patients with NVAF, including 336 patients from Japan.
In addition, the safety and efficacy of ELIQUIS in Japanese patients were evaluated in a subanalysis of the ARISTOTLE study, which demonstrated results consistent with the overall study.
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The U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date is March 17, 2013.
BMY shares closed at $32.46 on Monday, while PFE shares ended at $25.08.