FDA approval of Xarelto means anticoagulant options not so thin

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Those suffering from blood clotting disorders will find welcome relief in the FDA s approval of a new anticoagulant, rivaroxaban, co-developed by Johnson & Johnson and Bayer AG. The blood-thinner marketed under the brand name Xarelto is an oral drug, the second such drug to enter the potentially multi-billion dollar market of blood thinner medications, commonly used to prevent clots in the leg veins and in the heart among patients with the irregular heartbeat known as atrial fibrillation. Xarelto is the first new oral blood thinner drug approved for the prevention of a type of blood clot in the leg veins called deep venous thrombosis (DVT), seen in patients undergoing knee- and hip-replacement surgery. This condition can lead to lethal complications such as pulmonary embolism, when a leg vein clot breaks off and travels to the lung.

Last year, Boehringer Ingelheim s dabigatran (Pradaxa) was approved to prevent strokes associated with the heart rhythm disorder atrial fibrillation, which causes blood clots to form in the heart and, if untreated, circulate to the brain, resulting in a stroke. Johnson & Johnson and Bayer are hoping the FDA will approve its application to market Xarelto for this condition as well. Unlike Warfarin (Coumadin) an older drug that requires careful and frequent monitoring to prevent bleeding complications Xarelto can be taken just once daily and requires less frequent monitoring for its anticoagulant effect. Johnson & Johnson estimates the drug will cost only $6.75 per day.

ACSH's Dr. Gilbert Ross considers this new drug a welcome addition to the therapeutic options for preventing the potentially deadly cerebral emboli associated with stroke, as well as reducing the toll of lung emboli.