NDA Accepted for Eliquis for Prevention of Stroke and Systemic Embolism in Atrial Fibrillation
Bristol-Myers Squibb and Pfizer announced that the FDA has accepted its New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The submissions were based on the results of the ARISTOTLE and AVERROES studies, two Phase 3 trials that evaluated the efficacy and safety of Eliquis for the prevention of stroke or systemic embolism in patients with atrial fibrillation. These two trials, which included approximately 24,000 patients, comprise the largest completed clinical-development program for stroke prevention in atrial fibrillation among oral anticoagulants, and included patients eligible for anticoagulant therapy based on current treatment guidelines, as well as patients expected or demonstrated to be unsuitable for vitamin K antagonist therapy.
Eliquis is an oral direct Factor Xa inhibitor.
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