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news.Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has received recommendation from the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) for the approval of rivaroxaban as a preventive measure for stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
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The recommendation is based on the results from a double-blind Rocket AF Phase 3 trial which showed that once-daily rivaroxaban had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates
The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.
J&JPRD Cardiovascular and Metabolism Global Therapeutic Area head peter DiBattiste said they look forward to working with the FDA to help make this important therapy available in the US.