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Pfizer and BMS halt major ACS trial

Pfizer and Bristol-Myers Squibb have halted a study of oral anticoagulant apixaban in acute coronary syndrome due to bleeding in subjects

Pfizer and Bristol-Myers Squibb (BMS) have called a halt to a large phase III study of their oral anticoagulant drug apixaban in acute coronary syndrome (ACS) due to an increase in bleeding observed in subjects receiving the therapy.

The trial, called APPRAISE-2, was comparing apixaban to placebo in addition to antiplatelet therapy in patients with recent ACS.  The research was to have enrolled a total of 10,800 subjects and was being conducted in 40 countries.

An independent data monitoring committee advised that the study be stopped early due to a clinically important increase in bleeding among patients in the apixaban group that was not counterbalanced by clinically meaningful reductions in ischemic events.

BMS and Pfizer promised to publicly release a full evaluation of the available dataset from the APPRAISE-2 trial. Meanwhile, a phase II study of the drug in ACS patients in Japan is also being discontinued.

The companies said that they remain committed to developing apixaban in other indications.  The partners are currently working on a rolling submission of data to the US Food and Drug Administration (FDA) for the prevention of stroke in certain patients with atrial fibrillation, as well as an application to the European Medicines Agency (EMA) for venous thromboembolism prevention. The risk profile in these patients appears to be different than in the ACS patients, according to the companies.

BMS discovered apixaban and is co-developing and potentially commercializing the drug under a 2007 partnership with Pfizer.

19th November 2010

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