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Apixaban (Eliquis) Reduces Recurrence of Blood Clots in Phase III Trial
Drug awaits FDA approval (Dec. 8)
Results have been announced from the phase III AMPLIFY–EXT trial, which evaluated treatment with apixaban (Eliquis, Pfizer/Bristol-Myers Squibb) over a 1-year period compared with placebo for the prevention of recurrent venous thromboembolism (VTE) in patients who had already completed 6 to 12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE).
In the new study, extended treatment with apixaban 2.5 mg and 5.0 mg twice daily demonstrated superiority over placebo in reducing the composite endpoint of symptomatic, recurrent VTE and death from any cause (3.8% and 4.2% in the Eliquis 2.5-mg and 5.0-mg groups versus 11.6% in the placebo group; P < 0.001) — the trial’s primary efficacy endpoint.
Apixaban also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (1.7% in both the apixaban 2.5-mg and 5.0-mg groups versus 8.8% in the placebo group; P < 0.001).
The rate of the primary safety outcome of major bleeding was comparable across treatment groups (0.2% for apixaban 2.5 mg; 0.1% for apixaban 5.0 mg, and 0.5% for placebo). The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5.0-mg treatment group (4.3%) was higher versus that of the placebo group (2.7%), while the rate for the 2.5-mg treatment group (3.2%) was similar to that of the placebo group.
The new findings were announced during the 54th Annual Meeting of the American Society of Hematology (ASH) and were published online in the New England Journal of Medicine.
The randomized, double-blind AMPLIFY–EXT (Apixaban After the Initial Management of PuLmonary EmbolIsm and Deep Vein Thrombosis With First-Line TherapY–EXTended Treatment) trial included 2,486 patients with prior VTE who had completed 6 to 12 months of anticoagulation treatment for DVT or PE and who required continued anticoagulation therapy. The patients were randomized to receive apixaban (2.5 mg or 5.0 mg) or placebo twice daily for 12 months.
Apixaban is an oral direct Factor Xa inhibitor, part of a new therapeutic class. By inhibiting Factor Xa, a key blood-clotting protein, apixaban prevents thrombin generation and the formation of blood clots.
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the U.S.
Source: Pfizer; December 8, 2012.