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.

From detailed timelines and messaging tips to rules for crafting effective slides and handling the toughest questions, failure to anticipate even the smallest details can cost your company tens of millions or even hundreds of millions of dollars, and damage your reputation.

With FDAnews’ The FDA Advisory Committee Survival Manual, you will identify the biggest hurdles you’ll face in preparing for an advisory committee meeting, and plan the steps to overcome those hurdles.

Don’t put your investment and products at risk, order this must-have book today!