Bristol-Myers Squibb and Pfizer have announced that the US Food and Drug Administration (FDA) has extended the action date by three months for the new drug application for apixaban (Eliquis) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new prescription drug user fee act goal date is 28 June 2012.
Subsequent to the filing of the new drug application, the companies submitted additional information about the Eliquis clinical programme 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 new drug application for apixaban.
At this stage there are no plans for an FDA advisory committee meeting to review the new drug application for apixaban.
Apixaban 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 apixaban in the 27 countries of the European Union for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
Apixaban 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, randomised, double-blind phase 3 trials.