Bristol Seeks EU OK for Apixaban

Bristol-Myers Squibb Co. (BMY - Analyst Report) and Pfizer (PFE - Analyst Report) recently announced that they intend to seek European approval for apixaban, a drug aimed at preventing and treating clots in blood vessels. The companies will submit the application for the purpose in the first half of 2010. The oral drug is being developed and commercialized by the two companies through an agreement entered into in 2007.
 
The partners intend to seek approval for the candidate for treating patients who have undergone orthopedic surgery. The application will be supported by data from ADVANCE-2 and ADVANCE-3, studies which evaluated apixaban versus the European dosing regimen of enoxaparin for venous thromboembolisms (VTE) prevention in patients undergoing orthopedic surgery. The data from the ADVANCE-3 trial will be submitted for publication and presentation next year.
 
Players which are developing or selling new blood-clotting drugs include AstraZeneca (AZN - Analyst Report), Eli Lilly (LLY - Analyst Report), Bayer and Johnson & Johnson (JNJ - Analyst Report).
 
Apixaban is an oral factor Xa anti-thrombosis agent with prophylactic and therapeutic value in a number of indications such as prevention of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of stroke in patients with atrial fibrillation (AF), stroke associated with atrial fibrillation, and arterial thromboembolic events associated with acute coronary syndrome.

Read the full analyst report on BMY

Read the full analyst report on PFE

Read the full analyst report on AZN

Read the full analyst report on LLY

Read the full analyst report on JNJ