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An FDA advisory panel voted 9 to 2 on Thursday to recommend approval of rivaroxaban (Xarelto) for the prevention of strokes in patients with atrial fibrillation, Reuters reports.
The drug is one of several new agents that could replace warfarin in such patients.
According to Reuters, panelists debated potential issues with rivaroxaban, including whether it's truly as effective as warfarin. They noted that in ROCKET AF — the trial that demonstrated rivaroxaban's noninferiority to warfarin — warfarin was not always dosed properly, making comparisons between the two difficult.
The FDA will makes its final decision on rivaroxaban in November.
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LINK(S):
Reuters story (Free)
Physician's First Watch coverage of ROCKET AF (Free)