FDA Approves New Oral Anticoagulant From Daiichi Sankyo

January 9, 2015 12:50 AM

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Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace: dabigatran (Pradaxa) from Boehringer Ingelheim, rivaroxaban (Xarelto) from Johnson & Johnson, and apixaban (Eliquis) from Pfizer and Bristol-Myers Squibb. All four drugs were designed to overcome the limitations of warfarin, which has long been available as an inexpensive generic drug but which requires extensive monitoring and dose adjustment and has numerous interactions with other drugs and foods.

The FDA approved two indications for edoxaban: for reducing the risk of stroke in patients who have non-valvular atrial fibrillation and for treating deep vein thrombosis and pulmonary embolism in patients who have already been receiving an anticoagulant by injection or by infusion for 5 to 10 days.

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