PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--
Bristol-Myers Squibb Company(BMY) and Pfizer Inc. (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.
ARISTOTLE and AVERROES are part of an ongoing clinical development program for ELIQUIS, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase III trials.
The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in markets outside of the U.S., including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. On September 21, 2012, Bristol-Myers Squibb and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that ELIQUIS (apixaban) be granted approval for the prevention of stroke and systemic embolism in adult patients with NVAF and with one or more risk factors for stroke.
About Atrial Fibrillation
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that more than 5.8 million Americans and 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25 percent for individuals 40 years of age or older. One of the most serious medical concerns for individuals with atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes are attributable to atrial fibrillation in the U.S. Additionally, strokes due to atrial fibrillation are more burdensome than strokes due to other causes. Atrial fibrillation-related strokes are more severe than other strokes, with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year in patients who are not treated with an antithrombotic.
About ELIQUIS
ELIQUIS is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. ELIQUIS is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union plus Iceland and Norway for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
ELIQUIS is also being investigated in Phase III trials for the treatment of VTE.
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FDA Acknowledges Receipt of Resubmission of the ELIQUIS® (apixaban) New Drug Application to Reduce the Risk of Stroke ...