The U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.

Included in this PDF document are our analyses of the committee meeting and the briefing documents. We also are providing a breakdown of how each panel member voted as well as his/her comments during the discussion session. Additionally, we are providing a calendar of upcoming catalysts for stroke prevention in atrial fibrillation.

For the full report, please download the PDF version at the top of this page.

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