FDA Advisory Panel Shoots Down Janssen’s Xarelto for ACS Indication
An FDA advisory panel voted 6–4 late last month, with one abstention, against recommending approval of a new indication for Janssen’s oral anticoagulant Xarelto in patients with acute coronary syndrome (ACS).
Prior to the meeting, FDA reviewers expressed concern about missing trial data, but said Xarelto (rivaroxaban) significantly reduces cardiovascular (CV) death in ACS patients when taken twice daily at 2.5 mg. The drug is under review to reduce the risk of CV death, heart attack and stroke when used with aspirin, or with aspirin plus clopidogrel or ticlopidine. It has priority review and an FDA decision is expected by June 29.
Phase III data submitted by the sponsor also show the drug was nominally statistically significant in reducing all-cause mortality, according to documents released before the Cardiovascular and Renal Drugs Advisory Committee meeting.
While missing trial endpoints can lead to a panel’s disapproval, there are many things well within a drug- or devicemaker’s control that can help lead to an approval recommendation.
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