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FDA Panel Narrowly Rejects Xarelto for ACS
An FDA advisory committee has voted 6-4, with one abstention, against expanding the marketing indications for the factor Xa inhibitor rivaroxaban (Xarelto) to include treatment of acute coronary syndrome (ACS).
The vote by the Cardiovascular and Renal Drugs Advisory Committee was somewhat surprising given the positive review from FDA staff released two days before the meeting, but it signals a growing reluctance to expand indications based on data from a single trial.