FDA Acknowledges Receipt of Resubmission of the ELIQUIS
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (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.
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