Resounding FDA ‘no’ for new Xarelto indication

An FDA advisory committee has decided by all 10 voting members not to recommend rivaroxaban (Xarelto) for a new indication.

The drug is now unlikely to be approved by the FDA for the extended use in acute coronary syndrome (ACS). The submission was made by Janssen, a Johnson & Johnson company.

"We appreciate the thoroughness of the committee's review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke.

"We will work with the FDA to address questions raised today."

Paul Burton, vice-president, clinical development, Janssen research and development.

Related news:

Xarelto should not be approved in ACS says FDA panel (PMLiVE).

US FDA advisory panel rejects Janssen's oral anticoagulant Xarelto for acute coronary syndrome (Pharmabiz).

Reference link:

FDA advisory committee recommends against approval of the use of oral anticoagulant Xarelto to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (Johnson & Johnson press release).