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J&J seeks OK for fifth use of anticlotting drug

Associated Press Modified: May 9, 2012 at 3:15 pm •  Published: May 9, 2012

TRENTON, N.J. (AP) — Johnson & Johnson already is seeking approval for a fifth use for its promising new clot-preventing drug, following a proven strategy that has helped it turn other medicines into multibillion-dollar products.

The health giant's Janssen Research & Development unit said Wednesday that it has applied to the Food and Drug Administration to market its Xarelto to lower risk of clots forming around stents propping open arteries in the heart. While uncommon, that can cause heart attack or death.

Just last week, J&J applied for approval of the pill, known chemically as rivaroxaban, for treating venous thromboembolism, a preventable condition blamed for many hospital deaths. It occurs when blood clots form in large veins, often in the calves, and break free, travel to the lungs and cause a fatal artery blockage there.

Xarelto is part of a new group of blood thinners intended to supplant the longtime standard treatment, warfarin, which is cheap but requires frequent blood tests to get dosing right and can interact with numerous foods and other medicines.

Xarelto currently is marketed for two conditions — reducing risk of blood clots in patients after knee or hip replacement surgery, and reducing risk of stroke and other blood clots in people with a type of irregular heartbeat. The FDA is giving it a priority review for a fifth proposed use, to cut risk of heart attack or stroke in patients who've had a blood clot in the heart that caused a heart attack or dangerous chest pain.

Applying to sell the same product for multiple conditions and patient groups is a lucrative sales-boosting strategy that J&J executives call "a pipeline in a drug."

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