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GEN News Highlights : Jul 1, 2013

BMS, Pfizer Report Phase III Results for Acute Venous Thromboembolism Drug

Bristol-Myers Squibb and Pfizer this weekend presented results from their Phase III AMPLIFY trial evaluating Eliquis® (apixaban) as a single agent for the treatment of patients with acute venous thromboembolism (VTE), which includes symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Reporting in the New England Journal of Medicine and at the International Society on Thrombosis and Haemostasis Congress being held in Amsterdam, the companies showed that Eliquis demonstrated comparable efficacy to current standard of care in patients with DVT and/or PE, plus a 69% relative risk reduction for major bleeding compared with current standard of care.

“These results complement the previously published results for the AMPLIFY-EXT study,” the University of Perugia’s Giancarlo Agnelli, M.D., professor of internal medicine and lead investigator of the study, explained in a statement. “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.”

BMS and Pfizer said that, based on the results of both AMPLIFY and AMPIFY-EXT, they plan to initiate regulatory filings for the initial long-term treatment of VTE, as well as for extended prevention of recurrent VTE.