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FDA Clears Edoxaban

On Thursday, January 8, 2014, the FDA cleared edoxaban (Savaysa, Daiichi-Sankyo) for reducing risk of ischemic stroke in non-valvular atrial fibrillation (AFIB) and for treating DVT and PE in patients who have already been receiving an anticoagulant by injection or by infusion for 5 to 10 days.

The anticoagulant joins apixaban and rivaroxaban as the third direct anti-Xa anticoagulant, and rounds out the number of DOACs to four, including the DTI dabigatran. One edoxaban peculiarity is its superior effectiveness in renal insufficiency compared to patients with normal healthy renal function, causing the FDA to require a a boxed warning stating that edoxaban is less effective in AFIB patients whose creatinine clearance is >95 mL/min and that kidney function should be assessed prior to starting treatment. An FDA subgroup demonstrated that patients with a creatinine clearance >95 mL/min have a greater risk of stroke compared with similar patients treated with warfarin.

My thanks to Ali Sadeghi-Khomami PhD of Precision BioLogic, Inc for drawing attention to this announcement.

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