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Johnson & Johnson seeks new approval of Xarelto

Associated Press Published: May 2, 2012

NEW BRUNSWICK, N.J. (AP) — Johnson & Johnson said Wednesday it asked regulators to approve its anticlotting drug Xarelto as a treatment for blood clots in the legs that can travel to a patient's lungs.

The company filed for approval of Xarelto as a treatment for deep vein thrombosis and pulmonary embolism, and as a preventative treatment for recurring venous thromboembolism. Deep vein thrombosis is a blood clot in large veins, usually in the legs. Those blood clots sometimes dislodge and travel to the lungs, where they can block the pulmonary artery in a condition called pulmonary embolism that can be fatal.

Venous thromboembolism is a collective term for both problems. The company's Janssen Research & Development unit said about 900,000 U.S. patients have a venous thromboembolism per year, and about a third of them die.

Xarelto is an oral drug that is already approved as a treatment for patients with a common irregular heartbeat and for those undergoing hip or knee replacement surgery. Johnson & Johnson has also asked the FDA to approve it as a treatment for life-threatening blood clots in patients with acute coronary syndrome. That's a condition in which a narrowed blood vessel reduces flow to the heart muscle, causing a heart attack or unstable chest pain. A decision is due at the end of June.

Xarelto was first approved in July. Johnson & Johnson markets the drug in the U.S., and Bayer HealthCare sells it in other regions.

Shares of Johnson & Johnson fell 23 cents to $64.98 in morning trading.


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