Bristol-Myers (BMY), Pfizer (PFE) Receive EC Approval for ELIQUIS

Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) announced today that the European Commission has approved ELIQUIS® (apixaban) for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors. 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. This is the first regulatory approval in any market for ELIQUIS for stroke prevention in patients with nonvalvular atrial fibrillation.

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. The ELIQUIS clinical program is the only Phase 3 clinical program among the new oral anticoagulants to evaluate the safety and efficacy of ELIQUIS versus aspirin in patients who were unsuitable for vitamin K antagonist (VKA) therapy.

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