Bristol-Myers
Squibb Company(NYSE: BMY) and Pfizer
Inc. (NYSE: 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.