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Published on 30 July 2008

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Oral anticoagulant applies for FDA approval

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Bayer Healthcare’s partner, Johnson & Johnson Pharmaceutical Research and Development (J&JPRD), has submitted the new drug application (NDA) to the US Food and Drug Administration (FDA) for rivaroxaban.

The drug is a novel anticoagulant taken as one tablet, once daily, and is awaiting approval for its use in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Dr Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development said: “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.

“Current standards of anticoagulation therapy have limitations and new preventative therapies are needed. We are now on the cusp of revolutionising the care of patients undergoing hip and knee replacement surgery.”

On the 24 July, rivaroxaban was recommended for approval in Europe for the prevention of venous thromboembolism (VTE) following elective hip and knee replacement surgery.  It is also the first oral anticoagulant to demonstrate superior efficacy over the US approved twice-daily injectable regimen of enoxaparin.

The application for rivaroxaban is supported by data from the RECORD clinical programme, in which more than 12,500 orthopedic patients have been investigated.  This comprised four pivotal phase III clinical trials that compared rivaroxaban with enoxaparin where they both demonstrated similar safety profiles including low rates of major bleeding.

Almost 50,000 patients are planned to be evaluated in the total clinical development programme including trials in prevention and treatment of a broad range of acute and chronic blood-clotting disorders.

Upon FDA approval, rivaroxaban will be the first novel oral anticoagulant introduced in the US market for more than 50 years.

Johnson & Johnson



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