FDA’s Advisory Committee recommends approval of rivaroxaban

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The US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban (Xarelto, Bayer) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The committee voted 9-2 (with one abstention) in favor of approving rivaroxaban in this indication. A decision by the FDA is expected in early November 2011.

The Advisory Committee’s recommendation is not binding, but the FDA will consider the panel’s recommendation and deliberations, as well as the sponsors’ presentation in its assessment of the new drug application for rivaroxaban. This application was submitted by Bayer’s cooperation partner Johnson & Johnson Pharmaceutical Research & Development for rivaroxaban in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation on 5 January 2011.


The application for marketing authorisation for rivaroxaban in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation as well as the treatment of deep vein thrombosis and the prevention of recurrent deep vein thrombosis and pulmonary embolism has also been submitted for approval in Europe. In addition, rivaroxaban has been submitted for marketing approval in the prevention of stroke in patients with atrial fibrillation to the Japanese Ministry of Health, Labor and Welfare.

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