Bristol-Myers Squibb Company BMY and Pfizer PFE today
announced that the U.S. Food and Drug Administration (FDA) has acknowledged
receipt of the New Drug Application (NDA) resubmission for ELIQUIS^®
(apixaban) to reduce the risk of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation (NVAF). The FDA assigned a new Prescription
Drug User Fee Act (PDUFA) goal date of March 17, 2013. The FDA has deemed the
resubmission a complete response to its June 22, 2012 Complete Response Letter
that requested additional information on data management and verification from
the ARISTOTLE trial.
The ELIQUIS NDA is based on the results of the ARISTOTLE and AVERROES studies.
These clinical studies evaluated ELIQUIS in approximately 24,000 patients with
NVAF, in the largest clinical trial program conducted to date in this patient
population. The landmark ARISTOTLE trial compared apixaban to warfarin, the
standard of care, in more than 18,000 NVAF patients, while AVERROES compared
apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K
antagonist (VKA) therapy.
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