Eliquis filed at FDA for VTE-BMS/Pfizer

The FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) from BMS/Pfizer for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the reduction in the risk of recurrent DVT and PE. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 25, 2014.

Together, DVT and PE are known as Venous Thromboembolism (VTE), and continue to be a major cause of morbidity and mortality, with approximately 900,000 patients in the U.S. and approximately 1 million patients in the EU diagnosed every year. The sNDA submission is supported by results from two Phase III trials, AMPLIFY and AMPLIFY-EXT, which were both originally published in The New England Journal of Medicine on June 30, 2013, and December 8, 2012, respectively.