Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations

An FDA advisory committee recently considered a new drug application for rivaroxaban for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation, but there are important concerns about interpretation of the results of the key study. On September 8, 2011, the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed data submitted in support of the new drug application for rivaroxaban for preventing stroke and non–central nervous system systemic embolic events in patients with nonvalvular atrial fibrillation. Supportive evidence came primarily 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; ClinicalTrials.gov number, NCT00403767), 1 in which more than 14,000 patients were randomly assigned in a double-blind fashion to either 20 mg of rivaroxaban once daily or . . .