Xarelto ( Bayer // J & J ) . Comité asesor de la FDA de los EE. UU. ha rechazado ( 10 - 0 ) la solicitud de Bayer AG (BAYN) y Johnson & Johnson para ampliar el uso de su fármaco anticoagulante Xarelto, para tratar a los pacientes con Sindrome Coronario Agudo . ( Post by Celtia ) .

FDA advisory panel gives J&J's Xarelto resounding 'no' for ACS .

January 16, 2014 | By Carly Helfand .

An FDA advisory panel left no room for interpretation Thursday as to whether it thought the FDA should approve Johnson & Johnson's ($JNJ) Xarelto (rivaroxaban) as a treatment for acute coronary syndrome (ACS), delivering its "no" loud and clear at the end of the daylong hearing.

Panel members voted nearly unanimously to reject the drug, tallying 10-0 against with one abstention. As Reuters reports, the committee said data from a sole clinical trial, the ATLAS program, were not enough to get the drug approved--especially in light of the fact that some of the trial data were missing. That doesn't look good for Xarelto's FDA prospects, and the agency has already turned the drug away twice for ACS.

Paul Burton, VP of clinical development for J&J's Janssen R&D segment, said in a statement that the company would work with the FDA to address questions raised at the meeting. "We appreciate the thoroughness of the committee's review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke," he said.

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