Zoom imageBayer scientist Dr. Elisabeth Perzborn in the Wuppertal laboratory.
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving Xarelto™ (active ingredient: rivaroxaban) in two new indications: prevention of stroke in adult patients with atrial fibrillation, and treatment of deep-vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) in adult patients.
“The CHMP recommendation to approve rivaroxaban in these two additional indications is an important milestone for Bayer,” said Dr. Kemal Malik, member of the Board of Management of Bayer HealthCare and Head of Global Clinical Development. “We expect to soon be able to offer patients and doctors in the E.U. an effective alternative for stroke prevention in patients with atrial fibrillation and a novel, easy-to-use approach for the treatment of deep-vein thrombosis.”
The decision of the European Commission is expected in the fourth quarter of 2011. Once the approvals are granted, rivaroxaban will be the only novel anticoagulant for adult patients that can be used for three indications in all E.U. member states:
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prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and one or more risk factors;
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treatment of DVT and prevention of recurrent DVT and PE in patients after acute DVT;
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prevention of venous thromboembolism (VTE) in patients after elective hip or knee replacement surgery.
“The decision to recommend using rivaroxaban in these new indications confirms the product’s benefits in the treatment and prevention of potentially deadly blood clots in a wide spectrum of venous and arterial indications,” said Ajay Kakkar, Professor of Surgical Sciences at the University of London. “Patients have been waiting for more than 50 years for new therapeutic options that give better results than traditional treatments and are not subject to the familiar restrictions such as frequent monitoring, regular injections, dietary adjustments and interactions with other drug products,” said Eve Knight, Chief Executive and co-founder of AntiCoagulation Europe (ACE).
An Advisory Committee of the U.S. Food and Drug Administration (FDA) has likewise recommended granting regulatory approval for rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the United States. The FDA’s decision is expected in early November 2011.