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Bristol-Myers, Pfizer Says Eliquis Late-Stage Trial Meets Main Goal

6/30/2013 5:23 PM ET

Bristol-Myers Squibb Co. (BMY: Quote) and Pfizer Inc. (PFE: Quote) Sunday said its anti-clotting drug Eliquis proved to be as effective as standard therapy and caused significantly less bleeding complications in in treating patients with acute venous thromboembolism.

Eliquis met the main endpoint of the trial by demonstrating that it is not inferior to the current standard of care, ainitial parenteral enoxaparin treatment overlapped with warfarin therapy, in the reduction of recurrence of acute venous thromboembolism, or VTE, and related deaths.

Eliquis also met the primary safety endpoint of superiority for major bleeding, with a 69 percent relative risk reduction compared to current standard of care.

Eliquis, or apixaban, is an anticoagulant that was jointly developed by Bristol-Myers Squibb and Pfizer. Eliquis is approved for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery in the EU and other countries, but the drug has not been is not approved for this indication in the U.S.

"The study results showed that apixaban, as a single-agent, has comparable efficacy with significantly fewer major bleeding events with respect to the standard of care," said Dr. Giancarlo Agnelli, the lead investigator of the study. "Together these studies represent exciting data in the field of VTE treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for VTE patients."

Venous thromboembolism encompasses two serious conditions: deep vein thrombosis (DVT), a blood clot in a vein, usually in the leg; and pulmonary embolism (PE), a blood clot blocking one or more vessels in the lungs. Around 900,000 patients in the U.S. and about 1 million patients in the EU are diagnosed every year with VTE.

The study, dubbed AMPLIFY, (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY), included 5,395 patients. The study tested 10 mg of Eliquis twice daily for seven days followed by 5 mg twice daily thereafter compared to current standard of care.

PFE closed Friday at $28.01, down $0.17 or 0.60%, while BMY closed at $44.69, down $1.61 or 3.48%, both on the NYSE.

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by RTT Staff Writer

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