Bristol-Myers Squibb and Pfizer's Eliquis meets primary endpoints in Ph III VTE trial

1 July 2013

US drug giants Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) yesterday (June 30) announced positve results of a six-month Phase III trial of their anticoagulant Eliquis (apixaban) for the treatment of acute venous thromboembolism (VTE), including deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

In the AMPLIFY trial of 5,395 patients with VTE, Eliquis achieved the primary efficacy endpoint of non-inferiority to current standard of care (initial parenteral enoxaparin treatment overlapped with warfarin therapy) in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death.

In a joint statement the companies said Eliquis also met the primary safety endpoint of superiority for major bleeding, with a 69% relative risk reduction (RRR) for major bleeding compared to current standard of care. It said the study demonstrated comparable results for the primary efficacy and safety endpoints between patients entering the study with a DVT or a PE.

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