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Bayer HealthCare’s oral anticoagulant Xarelto

® (rivaroxaban) has been approved by the European Commission (EC) for use in two new indications, making it the only new oral anticoagulant approved in three indications across all 27 EU member states:

• Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

• Treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults

• The prevention of VTE in adult patients undergoing elective hip or knee replacement surgery

"Today’s approval in these new indications by the European Commission marks the culmination of years of intensive research, and underscores Bayer’s innovative strength," said Dr. Jörg Reinhardt, Chairman of the Bayer HealthCare Executive Committee. "We are delighted to bring the benefits of rivaroxaban to patients and physicians in the EU in

® Approved in the EU for the Prevention of Stroke in Patients with AF and in the Treatment of DVT

In stroke prevention in AF, Xarelto is the only oral anticoagulant offering patients a once-daily, highly effective therapy without need for routine coagulation monitoring

• For the treatment of DVT and the prevention of recurrent DVT and PE, Xarelto is the first oral anticoagulant to offer patients both efficacy and the convenience of a single-drug solution, without the need for injections or monitoring

• Xarelto is now approved in the EU across three indications in the area of venous and arterial thromboembolism (VAT)

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need of a highly effective and convenient therapy against blood clots to prevent strokes and treat DVT."

"These approvals have the potential to change clinical practice in Europe," said Professor Alexander G.G. Turpie, Professor of Medicine, McMaster University, Canada. "Rivaroxaban offers patients suffering from AF an effective and well-tolerated therapy option, while avoiding the drawbacks of traditional therapies. In the treatment of DVT and prevention of recurrent DVT and PE, physicians are now able to utilise a new single drug solution, making the therapy more convenient for both patients and physicians."

New England Journal of Medicine (NEJM) in August 2011.

The approval of rivaroxaban for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, follows submission of data from the Phase III EINSTEIN-DVT study, as well as data from the Phase III EINSTEIN-Extension study. Both EINSTEIN-DVT and EINSTEIN-Extension were published in the

NEJM in December 2010.

"The decision of the European Commission to approve this therapy is welcome news for people at risk of the devastating consequences of blood clots," said Eve Knight, Co-Founder and CEO of the charity AntiCoagulation Europe (ACE). "Thrombosis remains a massive burden on patients and healthcare systems across the EU, and the approval of effective alternatives without the limitations of traditional therapies such as routine monitoring, regular injections and dietary challenges represents a much needed evolution in thrombosis management."