Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY) announced Tuesday that the European Commission has approved Eliquis or apixaban for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation or NVAF with one or more risk factors.
The company said that Eliquis is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality.
Eliquis is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. It is the first regulatory approval in any market for Eliquis for stroke prevention in patients with nonvalvular atrial fibrillation, the company said.
The marketing authorization for Eliquis is supported by the pivotal Phase 3 trials Aristotle and Averroes, which evaluated approximately 24,000 patients with NVAF in the largest completed clinical trial program conducted to date in this patient population.
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that approximately 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25% for individuals 40 years of age or older.
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.
by RTT Staff Writer
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