US FDA delays Eliquis decision; Pristiq dropped for menopause

USA drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) say that the US Food and Drug Administration has extended the action date by three months for their New Drug Application 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.

Last spring, the European Commission has approved Eliquis in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery (the Pharma Letter May 23, 2011.