FDA approves Daiichi's Savaysa with boxed warning

FDA approved an NDA from Daiichi Sankyo Co. Ltd. (Tokyo:4568) for once-daily 15, 30 and 60 mg Savaysa edoxaban to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.

A boxed warning on the label notes Savaysa should not be used in NVAF patients with a creatinine clearance >95 mL/min due to an increased risk of ischemic stroke compared to warfarin. In its announcement, the company noted individuals with CrCL less than or equal to 95 mL/min represented 77% of the patients studied in the pivotal ENGAGE AF-TIMI 48 study. ...