Bayer files for EU approval of anticoagulant rivaroxaban for stroke prevention; updates on US filing

German drug major Bayer (BAY: DE) has submitted an application for marketing authorization to the European Medicines Agency (EMA) for its oral anticoagulant rivaroxaban in stroke prevention in patients with atrial fibrillation (SPAF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE).

Rivaroxaban is an oral direct Factor Xa inhibitor, and is being jointly developed by Bayer HealthCare and the USA’s Johnson & Johnson Pharmaceutical Research & Development (NYSE: JNJ), although the German firm will be responsible for sales of the drug outside the USA.

The drug, marketed as Xarelto, is used for the prevention and treatment of thrombosis - and approved in Europe for the prophylaxis of venous thromboembolism following hip and knee replacement surgery, but has generated negligible sales so far. However, "this innovative pharmaceutical has peak annual sales potential of more than 2 billion euros [$2.68 billion]," Wolfgang Plischke, the member of Bayer AG’s board of management responsible for innovation, technology and environment, said recently (The Pharma Letter December 9, 2010).