FDA declines to approve new clinical indication for Xarelto

RARITAN, N.J. — The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

Janssen confirmed the receipt of the CRL for Xarelto (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome. The drug maker submitted this sNDA in December 2011 and received a priority review designation from the FDA on Feb. 27. On May 23, the FDA's Cardiovascular and Renal Drugs Advisory Committee narrowly voted against recommending approval of Xarelto in this indication.

The drug currently is approved for three clinical uses: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery; to reduce this risk in people who have just had hip replacement surgery; and to reduce the risk of both hemorrhagic and thrombotic strokes, as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

Janssen is evaluating the CRL and will respond to the agency's questions.

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