Reuters: Regulatory News: UPDATE 1-US advisers reject new use for J&J/Bayer's Xarelto

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UPDATE 1-US advisers reject new use for J&J/Bayer's Xarelto May 23rd 2012, 20:53 Wed May 23, 2012 4:53pm EDT SILVER SPRING, Md. May 23 (Reuters) - U.S. advisers recommended against expanding the use of Johnson & Johnson's blood thinner Xarelto as a way to reduce the risk of new heart attacks and strokes in people with heart problems. A panel of outside experts to the Food and Drug Administration voted on Wednesday that the pill should not be approved for people with acute coronary syndrome. J&J developed the drug in partnership with German drugmaker Bayer AG . Xarelto is already approved to reduce the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery. It is also approved to prevent strokes among people with a type of irregular heartbeat called atrial fibrillation. But the companies wanted to expand its use to treat patients with acute coronary syndrome, which refers to people who have heart attacks or chest pain, usually because of a blocked coronary artery. About 1 million people in the United States are hospitalized each year after having an ACS episode, usually a heart attack, according to researchers. The trial tested Xarelto as an addition to aspirin, and other clot preventers like Bristol-Myers Squibb and Sanofi's Plavix. In a close vote of 6 to 4, with one abstention, most advisers said Xarelto looked promising but missing data could skew results. They were also concerned about bleeding risks. "I want to see better evidence that this strategy of adding (Xarelto) ...is robustly better for the patient," said Dr. Steven Nissen, panel member and chairman of cardiovascular medicine at the Cleveland Clinic. "And I just wasn't convinced." The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by the end of June. Link this Share this Digg this Email Reprints

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