Bristol-Myers Squibb Co. and Pfizer Inc. recently discontinued the Phase III APPRAISE-2 clinical trial in patients with recent acute coronary syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy—but in the end, apixaban looks promising despite this setback.
The decision to end the study early came after an independent data monitoring committee noted clear evidence of a clinically important increase in bleeding among patients randomized to apixaban, and that this increase in bleeding was not offset by clinically meaningful reductions in ischemic events.
The APPRAISE-2 Trial (Apixaban for Prevention of Acute Ischemic Events - 2) was one of nine clinical trials evaluating apixaban in patients at risk of various ischemic events, but its cessation has not brought the other trials to a halt.Apixaban is an investigational oral factor Xa inhibitor, a new class of agents being studied for the prevention and treatment of blood clots. Apixaban is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of eight completed or ongoing, randomized, double-blind Phase III trials. The apixaban Phase III trial program is evaluating the prevention of venous thromboembolism, prevention of stroke and other thromboembolic events in patients with atrial fibrillation and the treatment of venous thromboembolism. In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb, with an eye toward combining Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.
Comments
Post a Comment