FDA Reviewer Recommends Expanded Approval Of Bayer, J&J's Xarelto

A Food and Drug Administration medical reviewer recommended the agency expand the approval of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting drug Xarelto to treat patients with a heart problem known as acute coronary syndrome.

Xarelto, considered part of a new generation of blood-thinning drugs, was approved last year to prevent strokes in patients with a heart rhythm disorder called atrial fibrillation and is also approved for short-term use in patients undergoing knee or hip replacement surgery.

The companies are now seeking approval to market Xarelto for use in treating acute coronary syndrome, which occurs when a blood clot develops inside a coronary artery and reduces blood flow to the heart. As part of that process, Xarelto will be reviewed on Wednesday by an FDA advisory panel.

The panel, which is made up of non-FDA medical experts, is being asked vote on whether it thinks Xarelto should be approved and to discuss several issues including whether the drug should carry the agency's most stringent boxed warning discussing bleeding risks.

The FDA released its review of Xarelto in preparation for Wednesday's meeting. One of the agency's medical reviewers recommended Xarelto's approval to "reduce the risk of cardiovascular events in patients with acute coronary syndrome."

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com