J&J seeks FDA approval for fifth use of anticlotting drug

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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."

J&J's best success with the tactic probably is with Remicade, a biologic drug approved for about a dozen types of inflammatory immune disorders or patient groups. It's now J&J's top seller, likely to bring in about $6 billion this year.

The company also has gotten powerful antibiotic Levaquin approved for 13 types of infections, expensive biologic drug Procrit approved for anemia in three types of patients and its Ortho Tri-Cyclen birth control pill approved to fight acne — a big marketing advantage over other contraceptives.

After J&J gets initial approval of a new drug, often for a relatively uncommon condition, it continue studies aimed at winning approvals for disorders affecting many more patients. Other drugmakers increasingly have been trying the same strategy, particularly for cancer, immune disorder and psychiatric medicines.

Once a drug is on the market, doctors can prescribe it for any use, and may be influenced by research data in pending applications for new uses.

Drug company sales reps cannot legally promote drug uses not yet approved, but plenty have done so. Some drugs have had much higher sales for such unapproved, "off-label" uses than for approved uses.

In recent years, many major drugmakers have reached financial settlements with the U.S. government, generally for well over $1 billion, penalizing them for such behavior.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ—onPharma

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