The FINANCIAL — According to Bayer, the development of Xarelto (rivaroxaban), a novel oral anticoagulant, has taken another step forward. Phase II results in patients with acute coronary syndrome (ACS) have been chosen for the Late Breaking Clinical Trial session at the American Heart Association’s (AHA) upcoming Annual Meeting in New Orleans, USA. The presentation will be held on November 10th, 2008 by C. Michael Gibson, M.D., from Harvard Medical School, Boston, USA.
The data will report the results from the ATLAS ACS TIMI 46 trial (Anti-Xa Therapy to Lower cardiovascular events in addition to aspirin with / without thienopyridine therapy in patients with Acute coronary Syndrome), a large phase II dose-finding study for secondary prevention of ACS in patients with recent ACS, chaired by Prof. Eugene Braunwald from Harvard University, Boston, USA. As the standard of care differs across countries, the safety and efficacy of rivaroxaban was investigated on top of aspirin, or aspirin plus a thienopyridine versus placebo in a broad patient population. Rivaroxaban was given once-daily or twice-daily at total daily doses ranging from 5 mg to 20 mg. The study enrolled about 3,500 individuals who were treated for 6 months.
Rivaroxaban is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. With the early availability of Phase II data, the companies are now planning to accelerate the clinical development program in this indication by initiating Phase III earlier than the previously announced date of second half of 2009.
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