BioCentury
ARTICLE | Clinical News

Eliquis apixaban: Phase III data

July 15, 2013 7:00 AM UTC

The double-blind, international Phase III AMPLIFY trial in 5,395 patients with acute VTE - symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE) - showed that twice-daily oral Eliquis for 6 months met the primary endpoint of non-inferiority to conventional therapy consisting of subcutaneous enoxaparin followed by warfarin in reducing the incidence of a composite of recurrent symptomatic VTE or VTE-related death (2.3% vs. 2.7%, p<0.001 for non-inferiority). On secondary endpoints, Eliquis significantly reduced the incidence of a composite of VTE, VTE-related death or major bleeding vs. conventional therapy (2.8% vs. 4.5%, p=0.001), but there was no significant difference between treatment groups in the incidence of composites of VTE or death from cardiovascular causes (2.3% vs. 2.9%, p=0.18) and VTE or death from any cause (3.2% vs. 3.9%, p=0.16). On safety endpoints, the rates of major bleeding (0.6% vs. 1.8%, p<0.001) and of a composite of major bleeding or clinically relevant non-major bleeding (4.3% vs. 9.7%, p<0.001) were significantly lower for Eliquis compared to conventional therapy. Patients received twice-daily 10 mg Eliquis for 7 days followed by twice-daily 5 mg Eliquis for 6 months, or conventional therapy consisting of subcutaneous enoxaparin followed by warfarin. Data were published in the New England Journal of Medicine and presented at the International Society on Thrombosis and Hemostasis meeting in Amsterdam.

The partners previously reported data from the Phase III AMPLIFY-EXT trial in 2,486 patients with VTE who completed 6-12 months of prior anticoagulation therapy showing that twice-daily Eliquis for 1 year met the composite primary endpoint of reducing the incidence of symptomatic recurrent VTE or all-cause death vs. placebo (see BioCentury, Dec. 17, 2012). Based on the data from both AMPLIFY and AMPLIFY-EXT, Bristol-Myers and Pfizer plan to submit regulatory applications for Eliquis for the initial and long-term treatment of VTE, as well as for the extended prevention of recurrent VTE. The partners declined to disclose details. ...