Bristol-Myers, Pfizer to seek EU approval of blood-clotting drug

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Bristol-Myers Squibb of Princeton, N.J., and Pfizer of New York City will submit an application for regulatory approval of apixaban in Europe for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010.

Apixaban is an oral, highly selective Factor Xa inhibitor, a new class of agents being studied for the potential to prevent and treat blood clots in the veins and arteries.

The companies said that the application will be supported by ADVANCE-2 and ADVANCE-3, two clinical trials that evaluated apixaban versus the European dosing regimen of enoxaparin (Lovenox) for prevention of VTE in patients undergoing orthopedic surgery. Results of ADVANCE-2 were first presented in July at the 22nd Congress of the International Society on Thrombosis and Hemostasis in Boston. The ADVANCE-3 data will be submitted for publication and presentation in 2010.