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news.Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) has filed Rivaroxaban new drug application (NDA)with the US Food and Drug Administration (FDA) as a prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
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Rivaroxaban is an oral anticoagulant being evaluated for the prevention and treatment of a range of disorders in which blood clotting plays a major role.
According to J&JPRD, in clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions.
The NDA was based on data from 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) Phase 3 trial.