Bayer’s Xarelto® approved in the EU for the prevention of stroke in patients

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 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.”

The approval of rivaroxaban for the prevention of AF-related stroke is based on the important clinical benefits demonstrated in ROCKET AF, a rigorous, double-blind global Phase III study that compared once-daily rivaroxaban with warfarin in more than 14,000 patients. The results from the ROCKET AF trial were published in the 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.”

About Venous and Arterial Thromboembolism (VAT)

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous and Arterial Thromboembolism (VAT) is caused when a clot becomes loose and is moved by the blood stream to obstruct another vessel, which can cause damage to vital organs. VAT encompasses two serious conditions:

• Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to another vessel which delivers blood to an organ. If this occurs in a vessel supplying blood to the lungs, it is known as a pulmonary embolism (PE), which can be rapidly fatal.
• Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying the brain, this can lead to a stroke, which can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina.

VAT is an important cause of morbidity and mortality across a broad range of acute and chronic blood-clotting disorders and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.