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Bayer Says International Study Affirms Xarelto's Benefits In Venous Blood Clots

4/17/2012 6:52 AM ET

Bayer HealthCare, a subsidiary of the German conglomerate Bayer AG (BAYRY.PK,BAYZF.PK), Tuesday said an international study that examined the safety and efficacy of Xarelto (rivaroxaban) in preventing potentially deadly venous blood clots reaffirmed the benefits of the drug.

The study, which Bayer calls real-world XAMOS study, assessed rivaroxaban in preventing venous blood clots (venous thromboembolism) in adults, following elective total hip or knee replacement surgery. The study reaffirmed the benefits of the oral, once-daily anticoagulant in everyday clinical practice.

Bayer also said XAMOS supports the clinical findings of and earlier trial programme, which showed oral, once-daily rivaroxaban to have consistently superior efficacy as well as a comparable and good safety profile to injectable enoxaparin.

Rivaroxaban, marketed under the brand name Xarelto, was discovered in Bayer HealthCare's Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Janssen Research & Development, LLC.

A.G.G. Turpie, Professor of Medicine, McMaster University, Canada and Chairman of the XAMOS Executive Steering Committee stated, "As the largest analysis of everyday clinical experience with a new oral anticoagulant, XAMOS offers real-world evidence and confidence that oral, once-daily rivaroxaban is safe and effective in protecting against dangerous blood clots in the orthopaedic setting - and importantly without the inconvenience and discomfort of current standard injectable treatments."

The non-interventional XAMOS study compared outcomes observed in everyday clinical practice across 17,413 orthopaedic patients receiving rivaroxaban or conventional pharmacological treatments for blood clot prevention.

The incidence of symptomatic thromboembolic events was lower in patients treated with rivaroxaban compared with conventional therapy.

In the U.S., rivaroxaban is available since July 2011 and Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit, holds marketing rights.

Last week, Bayer HealthCare said it has submitted an application to the European Medicines Agency seeking marketing authorization for Xarelto. In mid-January, Bayer announced that Xarelto has been approved by the Japanese Ministry of Health, Labor and Welfare.

On Frankfurt's Xetra, Bayer shares are currently trading at 51.84 euros, up 1.77 percent, on a volume of 764 thousand shares.

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by RTT Staff Writer

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