FDA Accepts ELIQUIS® Supplemental New Drug Application for Review
Fri, 12/20/2013 - 8:18am
Bristol-Myers Squibb Company and Pfizer have announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for ELIQUIS ® (apixaban) 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 3 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. AMPLIFY, ( A pixaban for the initial M anagement of P u L monary embol I sm and deep vein thrombosis as First-line therap Y ), a randomized, double-blind, multicenter trial, included 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months, and evaluated ELIQUIS (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) compared to current standard of care (initial parenteral enoxaparin treatment overlapped by warfarin therapy). AMPLIFY-EXT ( A pixaban after the initial Management of P u L monary embol I sm and deep vein thrombosis with First-line therap Y - EXT ended Treatment), a randomized, double-blind, multicenter trial, included 2,486 patients with prior VTE who had completed 6 to 12 months of anticoagulation treatment for DVT or PE. Patients were randomized to receive either ELIQUIS 2.5 mg or 5 mg, or placebo twice daily for 12 months.
Additionally, in November 2013 the European Medicines Agency accepted for review an application for ELIQUIS for the treatment of DVT and PE, and prevention of recurrent DVT and PE.