FDA Accepts Eliquis sNDA

The FDA has accepted for review an 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, according to the drug’s developers, Bristol-Myers Squibb and Pfizer.

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. AMPLIFY, 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 randomized, double-blind, multicenter trial, included 2,486 patients with prior VTE who had completed six 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.

In November 2013 the EMA accepted for review an application for Eliquis for the treatment of DVT and PE, and prevention of recurrent DVT and PE.