11/5/2012 8:20:51 AM
Johnson & Johnson (JNJ) and Bayer AG (BAYN), makers of stroke preventative Xarelto, won U.S. Food and Drug Administration approval for wider use of the medicine to treat blood clots in the legs and lungs and stave off recurrences. Bleeding, the major side effect with the blood thinner, is similar to other anti-clotting drugs, the FDA said today in a statement. Xarelto can now be used to treat clots from deep vein thrombosis in the legs, which can travel to the lungs and block an artery, a condition called pulmonary embolism that kills 30 percent of sufferers, the National Institutes of Health said. The leg and lung clots can affect as many as 600,000 people in the U.S. each year and together are known as venous thromboembolism. Xarelto’s use in lung and leg clots may account for $600 million of a projected $4.2 billion in peak annual sales of the medicine, Jeffrey Holford, an analyst at Jefferies Group Inc. in New York, said in an e-mail. “Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s drug evaluation center, said in the statement.
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