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22-06-2012 01:57:00

J&J: FDA Declined Approval for Expanded Use of Xarelto

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By Nathalie Tadena

Johnson & Johnson (JNJ) said the U.S. Food & Drug Administration didn't approve the expanded use of its anticlotting drug Xarelto for the treatment of patients with a heart problem known as acute coronary syndrome.

J&J, which developed Xarelto with Bayer AG (BAYRY, BAYN.XE), said it is evaluating the FDA's complete-response letter and will work with the agency to fully address its questions as quickly as possible.

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

J&J and Bayer are 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.

Last month, an FDA advisory panel narrowly voted against the expanded approval of Xarelto because of concerns about life-threatening bleeding.

J&J shares were up by a penny to $66.40 after hours. The stock is up 2.5% over the past three months.

Write to Nathalie Tadena at nathalie.tadena@dowjones.com

(END) Dow Jones Newswires

June 21, 2012 19:57 ET (23:57 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

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