VIENNA (dpa-AFX) - The U.S. FDA has approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation occurs when the heart's two upper chambers (atria) do not contract properly, allowing blood clots to form, which can break off and travel to the brain or other parts of the body. Savaysa is made by Tokyo-based Daiichi Sankyo Co., Ltd.
Savaysa also has been approved to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for five to ten days. Deep vein thrombosis is a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. A potentially deadly condition called pulmonary embolism results when a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow.
Daiichi Sankyo said the approved indications in the U.S. for SAVAYSA are based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies. The most common side effects observed in clinical trial participants were bleeding and anemia. SAVAYSA is expected to be commercially available in the U.S. in February 2015.
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