FDA panel likely to be rough ride for J&J/Janssen anticoagulant Xarelto
This article was originally published in Scrip
If the tone of the briefing documents the FDA released ahead of the 16 January meeting of its Cardiovascular and Renal Drugs Advisory Committee (CRDAC) are any indication, Johnson & Johnson unit Janssen is headed for another rough ride at the panel's second look at Xarelto (rivaroxaban) in combination with aspirin plus a thienopyridine as a therapy to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).
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