The FINANCIAL -- Berlin,
Germany, September 9, 2011 – Bayer HealthCare announced today that the
U.S. Food and Drug Administration’s (FDA’s) Cardiovascular and Renal
Drugs Advisory Committee recommended approval of rivaroxaban (Xarelto®)
for the prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation (AF) in the U.S.
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 (NDA) for rivaroxaban. The New Drug Application was submitted by Bayer’s cooperation partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) for rivaroxaban in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation on January 5, 2011.
Bayer holds the marketing rights for rivaroxaban in all markets outside the U.S., while Bayer’s cooperation partner Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company) has the rights to market the product in the U.S.
As previously communicated, 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 DVT and the prevention of recurrent DVT and PE has been submitted to the EMA 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 (MHLW).
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