Bristol-Myers Squibb, Pfizer To Stop Averroes Study Due To Evidence Of Efficacy

Bristol-Myers Squibb and Pfizer said that the Averroes study is expected to be stopped early because a predefined interim analysis by an independent Data Monitoring Committee (DMC) showed clear evidence of a reduction in stroke and systemic embolism in patients with atrial fibrillation considered intolerant of or unsuitable for vitamin K antagonist therapy who received Apixaban as compared to Aspirin.

Apixaban is being investigated within the Expanse Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide and includes a total of nine completed or ongoing, randomised, double-blind Phase 3 trials, including Averroes.

The Averroes study which was coordinated by the Population Health Research Institute (PHRI) at McMaster University and at Hamilton Health Sciences included 5,600 patients who were randomised to receive either Apixaban 5mg twice daily or Aspirin 8mg to 324mg once daily.

Bristol-Myers Squibb and Pfizer are working to stop the study and ensure that patients are informed of the opportunity to start treatment with Apixaban in an open-label extension. PHRI is expected to complete a full evaluation of the final AVERROES data set publish the results in a peer reviewed journal and present the findings at a scientific congress after the full analysis is complete.