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DVT drug performs well in trial

Bayer has received positive phase III results for its oral anticoagulant rivaroxaban, for use in patients with acute symptomatic deep vein thrombosis

Bayer has received positive phase III results in the EINSTEIN-DVT clinical trial of its oral anticoagulant rivaroxaban. The drug is being tested for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT).

"Results from EINSTEIN-DVT could transform the way physicians treat deep vein thrombosis," said lead investigator Dr Harry R Büller, who presented the results at the European Society of Cardiology (ESC) Congress.

"While the current standard of care is effective when well-controlled, it is often associated with significant drawbacks for patients and physicians. A novel single-drug approach such as oral rivaroxaban could potentially provide an effective and well-tolerated, simple, fixed-dose regimen for the treatment of deep vein thrombosis as a replacement for current standard therapy."

The current standard of care for DVT includes two compounds: enoxaparin, administered by subcutaneous injection, followed by a vitamin K antagonist (VKA).

Rivaroxaban, which is currently marketed under the brand name Xarelto for VTE prevention in adult patients following elective hip or knee replacement surgery, was shown to demonstrate equivalent efficacy in primary efficacy outcome compared to this standard therapy for patients with acute symptomatic DVT.

Safety outcomes were also demonstrated to be similar, with rivaroxaban well-tolerated overall.

Rivaroxaban was also found to improve on current treatments for a secondary outcome of the trial defined as the composite of the primary efficacy outcome plus major bleeding.

Bayer will begin regulatory filings for rivaroxaban in this treatment area later this year.

31st August 2010

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