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Sunday, March 13, 2011

August 5, 2010 - Bayer's Rivaroxaban Reported Equal To Standard Treatement In Preventing DVT and PE

Bloomberg News (8/5, Kresge) reports that Bayer AG's Xarelto [rivaroxaban] drug was equivalent to standard therapy of enoxaparin and warfarin to prevent blood clots in the lungs and legs. Study participants "taking the anti-clotting pill were as likely to develop serious and uncontrolled bleeding, a potential side effect of the medicine, as those on the standard therapy combination, Bayer said in a statement, citing results of a late-stage clinical trial. Xarelto beat the standard therapy on a measure that counted only clot prevention and the most serious bleeding." Xarelto is currently approved in the EU for the prevention of clots following knee and hip replacement. The drugmaker has to refile its US application for this indication because the FDA requested more data on the drug. The company has indicated that it intends to refile later this year.