Bristol-Myers Squibb and Pfizer announced that the FDA has approved Eliquis (apixaban tablets) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). 

Eliquis is an oral direct Factor Xa inhibitor that inhibits free and clot-bound Factor Xa and prothrombinase activity. It does not require antithrombin III for antithrombotic a and it indirectly inhibits platelet aggregation induced by thrombin. 

Eliquis was evaluated in two major Phase 3 studies – ARISTOTLE and AVERROES – in patients with nonvalvualr atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE evaluated Eliquis vs. warfarin in 18,201 patients and AVERROES evaluated Eliquis vs. aspirin in 5,598 patients.

Eliquis will be available in 2.5mg and 5mg dosage strength tablets in 60- and 180-count bottles by the end of January 2013.

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