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Published on 6 January 2011

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Johnson & Johnson submit FDA application

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Raritan, NJ (January 5, 2011) – Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

The submission is supported by data from the pivotal, global Phase 3 ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial.

AF is the most common sustained cardiac rhythm disorder, affecting more than 2.3m people in the U.S.

In patients with AF, the heart’s irregular beat makes them vulnerable to the formation of blood clots in the atria, which can travel to the brain, potentially resulting in a stroke.

Strokes can lead to major physical and behavioral impairments, or even death.

People living with AF are at a five-fold increased risk for stroke compared with the general population, and almost one-third will suffer from a stroke in their lifetimes.

J&JPRD also announced today that it has submitted its complete response to the 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.

The submission includes specific information requested by the FDA in a complete response letter issued to J&JPRD on May 28, 2009, and is primarily supported by data from the pivotal, global Phase 3 RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.

More information about the rivaroxaban clinical development program, and the diseases for which it is being developed, may be accessed here.



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