BioCentury
ARTICLE | Clinical News

Eliquis meets in Phase III for acute VTE

July 2, 2013 12:35 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) and partner Pfizer Inc. (NYSE:PFE) said twice-daily oral Eliquis apixaban for six months met the primary endpoint of non-inferiority to conventional therapy consisting of subcutaneous enoxaparin followed by warfarin in the Phase III AMPLIFY trial to treat acute venous thromboembolism (VTE). Eliquis was non-inferior to conventional therapy 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 safety endpoints, the rates of major bleeding (0.6% vs. 1.8%, p<0.001) and 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. The double-blind, international trial enrolled 5,395 patients with acute VTE. 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 VTE patients who completed 6-12 months of prior anticoagulation therapy showing that twice-daily Eliquis for one year met the composite primary endpoint of reducing the incidence of symptomatic recurrent VTE or all-cause death vs. placebo (see BioCentury Extra, Dec. 10, 2012). ...