Bristol-Myers (BMY) and Pfizer (PFE) Provide Update on Apixaban Clinical Development Program - Primary Endpoint Not Met
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Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE) provided an update on the apixaban clinical development program today. The companies announced that new Phase II data in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC). In addition, Bristol-Myers Squibb and Pfizer reported that an early evaluation of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement indicates that the primary endpoint of this study was not met.
The rate of the primary efficacy endpoint on apixaban was numerically similar to that observed with enoxaparin (9.0% vs. 8.9%, p=.064), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin.
The actual enoxaparin VTE rate of 8.9 percent was lower than the expected VTE rate of 16 percent seen in previous similar clinical trials, resulting in an inability to demonstrate non-inferiority.[SM]
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