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news.Bayer has submitted an application for marketing authorisation to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE).
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Rivaroxaban is an oral direct Factor Xa inhibitor, which is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD).
The submission for stroke prevention in patients with non-valvular AF is supported by results from the pivotal, global Phase III ROCKET AF trial, while submission for the treatment of DVT, and prevention of recurrent DVT and PE, is based on results from the Phase III EINSTEIN-DVT trial.
Bayer also confirmed that J&JPRD filed its complete response with the US Food & Drug Administration (FDA) seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery.
This filing was in response to the information requested by the FDA in a Complete Response Letter on May 28, 2009.
Rivaroxaban is approved in the European Union for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.