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Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:
Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily injection of enoxaparin while maintaining low rates of major bleeding / No evidence of safety issues attributable to rivaroxaban after long-term exposure
Leverkusen, July 30, 2008 - Bayer's cooperation partner Johnson & Johnson
Pharmaceutical Research and Development (J&JPRD) has submitted the new drug
application (NDA) to the U.S. Food and Drug Administration (FDA) for
rivaroxaban (Xarelto®), a novel anticoagulant taken as one tablet, once-daily.
It seeks approval for the use of rivaroxaban in the prevention of deep vein
thrombosis and pulmonary embolism in patients undergoing hip or knee
replacement surgery.
Rivaroxaban was invented in Bayer's Wuppertal laboratories and is being jointly
developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. Once marketing authorization has been granted in the U.S.,
rivaroxaban will be commercialized by Ortho-McNeil, a Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Rivaroxaban is the first oral anticoagulant to demonstrate superior efficacy
over the U.S. approved twice-daily injectable regimen of enoxaparin, with a
similar safety profile and no significant increase in major bleeding. Upon FDA
approval, rivaroxaban will be the first novel oral anticoagulant introduced in
the U.S. market for more than 50 years.
In addition to the FDA submission, filings are under review with regulatory
agencies around the world. On July 24, rivaroxaban was recommended for approval
in Europe for the prevention of venous thromboembolism (VTE) following elective
hip and knee replacement surgery.
"We are pleased to see rivaroxaban take an important step toward regulatory
approval so swiftly after demonstrating unparalleled success in the robust
clinical trial program," said Dr. Kemal Malik, member of the Bayer HealthCare
Executive Committee, responsible for product development. "Current standards of
anticoagulation therapy have limitations and new preventative therapies are
needed. We are now on the cusp of revolutionizing the care of patients
undergoing hip and knee replacement surgery."
The NDA in the U.S. is supported by data from the RECORD clinical program, in
which more than 12,500 orthopedic patients have been investigated - the largest
ever conducted in the prevention of VTE in patients undergoing knee or hip
replacement surgery. It 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 all four trials, rivaroxaban and enoxaparin
demonstrated similar safety profiles including low rates of major bleeding.
Almost 50,000 patients are planned to be evaluated in the total clinical
development program which includes trials in prevention and treatment of a
broad range of acute and chronic blood-clotting disorders. Based on the
clinical evidence reported to date from over 32,000 patients (of which more
than 18,000 patients have been exposed to rivaroxaban), no safety issues
attributable to rivaroxaban have been observed. This includes long-term
exposure of approximately 7,000 patients treated with rivaroxaban for at least
3 months of which approximately 4,500 patients were treated with rivaroxaban
for 6 to 12 months or longer. A more definitive statement will be made once the
data from long-term exposure to rivaroxaban in the VTE treatment, the acute
coronary syndrome and stroke prevention in atrial fibrillation (SPAF) programs
are available.
In the U.S., more than 900,000 people suffer from VTE events annually, and
300,000 Americans die from VTE every year. Each year, approximately 700,000
Americans elect to have hip and knee replacement surgeries, and a blood clot is
the most common cause of re-hospitalization for this patient group.
Bayer estimates the global peak sales potential of rivaroxaban for all
indications to exceed EUR 2 billion.
Please visit www.thrombosisadviser.com to learn more about VTE.
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.
