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
“These approvals have the potential to change clinical practice in Europe,” said Professor Alexander 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.”