The US 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 US FDA accepted the filing and assigned a priority-review designation for Bristol-Myers Squibb Company and Pfizer Inc's Eliquis NDA. 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 III 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 programme 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.
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the US. It 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 Programme, 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 III trials.
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. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.