The FDA has extended the action date by three months for the New Drug Application (NDA) for apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new Prescription Drug User Fee Act goal date is June 28.
The FDA assigned priority review designation for apixaban in November 2011, when the agency initially accepted its NDA. At that time, the action date was set for March 28. Subsequent to the filing of the NDA, the companies submitted additional information about the apixaban clinical program to the FDA, which constitutes a major amendment to the application and will require additional time for review. The companies said they "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.