FDA to Review Eliquis sNDA for DVT/PE Treatment

Bristol-Myers Squibb Company and Pfizer announced that the 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. Eliquis is an oral direct Factor Xa inhibitor.

The sNDA submission was based on results from two Phase 3 trials, AMPLIFY and AMPLIFY-EXT. AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) was a randomized, double-blind, multicenter trial that included 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months. The study evaluated Eliquis 10mg twice daily for 7 days followed by 5mg twice daily thereafter compared to current standard of care, initial parenteral enoxaparin treatment overlapped by warfarin therapy.

AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY–EXTended Treatment), a randomized, double-blind, multicenter trial, included 2,486 patients with prior VTE who had completed 6–12 months of anticoagulation treatment for DVT or PE. Patients were randomized to receive either Eliquis 2.5mg or 5mg, or placebo twice daily for 12 months.

Eliquis is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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