Rivaroxaban Phase II Data in ACS to be Presented at AHA Congress in November 2008
First data presentation from large dose-finding trial involving about 3,500 patients / Acceleration of clinical development in acute coronary syndrome planned
Leverkusen, August 31, 2008 – 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.
The extensive clinical trial evidence supporting rivaroxaban makes it the most studied oral direct Factor Xa inhibitor in the world today. Almost 50,000 patients are expected to be enrolled into the rivaroxaban clinical development program which will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders including VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalized, medically ill patients and secondary prevention of acute coronary syndrome.
The RECORD clinical program, in which more than 12,500 orthopedic patients have been investigated, has been completed. It is the largest program ever conducted in the prevention of VTE in patients undergoing knee or hip replacement surgery and comprised four pivotal Phase III clinical trials that compared rivaroxaban with enoxaparin. Rivaroxaban demonstrated superior efficacy over enoxaparin in head-to-head comparisons (RECORD1, 3 and 4), and a comparison of extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). In RECORD4, rivaroxaban was the first oral anticoagulant to demonstrate superior efficacy over the U.S. approved twice-daily injectable regimen of enoxaparin. In all four trials, rivaroxaban and enoxaparin demonstrated similar safety profiles including low rates of major bleeding.
Rivaroxaban has recently been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the prevention of venous thromboembolism in patients undergoing elective (planned) hip or knee replacement surgery. Bayer expects the marketing authorization across all EU-member states very soon. Additional filings are under review with regulatory agencies in more than 10 other countries worldwide, including the United States.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
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