Application for regulatory approval of apixaban in Europe to be submitted

Editorial Checklist Reviewed
Dec 4 2009

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) today announced that the companies are planning to 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. The application will be supported by ADVANCE-2 and ADVANCE-3, two clinical trials that evaluated apixaban versus the European dosing regimen of enoxaparin for prevention of VTE in patients undergoing orthopedic surgery. Results of ADVANCE-2 were first presented in July 2009 at the 22nd Congress of the International Society on Thrombosis and Haemostasis in Boston. The ADVANCE-3 data will be submitted for publication and presentation in 2010.

Apixaban is a novel, 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.

Source:

http://www.bms.com/

Posted in: Pharmaceutical News

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