FDA sets date for Eliquis once again

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The FDA has set a goal date of March 17, 2013, to review apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The announcement follows a recent recommendation by the European Medicines Agency’s regulatory committee to approve apixaban for the prevention of stroke and systemic embolism in adult patients with nonvalvular AF in the European Union (EU). The committee’s positive opinion will be reviewed by the European Commission.

Bristol-Myers Squibb and Pfizer reported Sept. 26 that the FDA acknowledged receipt of the New Drug Application (NDA) resubmission for apixaban after the agency requested additional information in June on data management and verification from the ARISTOTLE trial. The review date has been extended several times, despite ARISTOTLE researchers reporting that apixaban was superior to warfarin in reducing stroke and systemic embolism in AF patients.

The FDA first assigned it priority review designation in November 2011 with an action date of March 28. In March, the FDA assigned a new goal date of June, which was again extended when the FDA issued a complete response letter for the NDA.

The NDA is based on the results of the ARISTOTLE and AVERROES studies, which evaluated apixaban in approximately 24,000 nonvalvular AF patients. The ARISTOTLE trial compared apixaban to warfarin, the standard of care, in more than 18,000 nonvalvular AF patients, while AVERROES compared apixaban with aspirin in 5,598 nonvalvular AF patients who were unsuitable for vitamin K antagonist therapy.

Apixaban, a direct factor Xa inhibitor, received regulatory approval in 2011 in 27 EU countries for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery. It has yet to be approved for any indication in the U.S.