Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Eliquis (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 28, 2012.
As previously disclosed, an application for Eliquis for stroke prevention in atrial fibrillation has been validated for review by the European Medicines Agency.
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 novel 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 (VKA) therapy.
About Atrial Fibrillation
Atrial fibrillation is the most common sustained cardiac arrhythmia, or irregular heart beat. It is estimated that more than 5 million Americans and 6 million individuals in Europe have atrial fibrillation. The lifetime risk of atrial fibrillation is estimated to be approximately one in four for individuals 40 years of age or older. The most serious medical issue for individuals with atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes in the U.S. are attributable to atrial fibrillation. Additionally, strokes due to atrial fibrillation are more burdensome than strokes due to other causes. Atrial fibrillation-related strokes are more severe than other strokes with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year.
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. Eliquis is not approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for Eliquis in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Eliquis is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.