Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration or FDA has acknowledged receipt of the New Drug Application or NDA resubmission for Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation or NVAF.
Bristol-Myers stated that 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.
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat).
The companies said that they 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 or 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.
Bristol-Myers said 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.
For comments and feedback contact: editorial@rttnews.com
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.