FDA advisory panel rejects J&J drug for acute coronary syndrome

Thu Jan 16, 2014 4:04pm EST

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(Reuters) - Johnson & Johnson's anticoagulant Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The panel voted 10 to 0, with one abstention, against approval, saying data from a single clinical trial was not strong enough to justify approval, especially since some data from the trial was missing.

Xarelto is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.

(Reporting by Toni Clarke in Washington; Editing by Bernard Orr)

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