Bristol-Myers Squibb Company and Pfizer 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 orthopaedic 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 for prevention of VTE in patients undergoing orthopaedic 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.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field to maximize the potential benefits of apixaban for patients.