Bristol-Myers Squibb Company, a global biopharmaceutical company, and Pfizer announced that the US Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new Prescription Drug User Fee Act (PDUFA) goal date is June 28, 2012.
Subsequent to the filing of the NDA, the companies submitted additional information about the Eliquis clinical program to the FDA which constitutes a major amendment to the application and will require additional time for review. The companies will continue to work closely with the agency to support the continued review of the NDA for Eliquis.
At this stage there are no plans for an FDA advisory committee meeting to review the NDA for Eliquis.
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 or systemic embolism in patients with atrial fibrillation in any country. 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.
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.