Bristol-Myers Squibb and Pfizer file for apixaban approval in Europe

Bristol-Myers Squibb, along with its pharmaceutical partner Pfizer, has announced the submission of a regulatory approval request for the venous thromboembolism (VTE) drug apixaban in Europe.

The drug is set to be evaluated during the first half of 2010 for the prevention of VTE after orthopedic surgery.

Prior to the application, two clinical trials, entitled ADVANCE-2 and ADVANCE-3, evaluated the efficacy of apixaban versus the existing European dosing regimen of enoxaparin.

Apixaban, which is a novel, oral factor Xa inhibitor, is among a new class of agents currently being examined for their potential to prevent and treat blood clots in arteries and veins.

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide partnership to develop and commercialise the treatment.

In other Bristol-Myers Squibb news, the firm announced earlier this month that it had entered into a partnership with the National AIDS Fund, which is designed to introduce AIDS and HIV treatment, care and support to those who have not previously been able to access it.