BMS, Pfizer Resubmit NDA for Eliquis (Apixaban) to Reduce Stroke in Patients With Atrial Fibrillation
FDA review set for March 2013 (Sept. 26)
Bristol-Myers Squibb Company and Pfizer Inc. announced on September 26 that the FDA has acknowledged receipt of the companies’ new drug application (NDA) resubmission for the oral anticoagulant 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 agency deemed the resubmission a complete response to its June 22 Complete Response Letter requesting additional information on data management and verification from the ARISTOTLE trial.
The Eliquis NDA is based on results from the ARISTOTLE and AVERROES trials. These clinical studies evaluated Eliquis in approximately 24,000 patients with NVAF. The landmark ARISTOTLE trial compared apixaban with warfarin, the standard of care, in more than 18,000 NVAF patients, and AVERROES compared apixaban with aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist (VKA) therapy.
Eliquis is the approved trade name for apixaban in Europe and is 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.
It is estimated that more than 5.8 million Americans have atrial fibrillation (AF). The lifetime risk of developing the disorder is approximately 25% for individuals 40 years of age or older. One of the most serious medical concerns for individuals with AF is the increased risk of stroke, which is five times higher in people with AF than in those without AF. Fifteen percent of all strokes are attributable to AF in the U.S. AF-related strokes are more severe than other strokes, with an associated 30-day mortality rate of 24% and a 50% likelihood of death within 1 year in patients who are not treated with an antithrombotic.
For more information, visit the Bristol-Myers Squibb Web site.