FDA panel backs Daiichi's edoxaban

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-1 to recommend approval of Savaysa edoxaban from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), but opinions differed on how the anticoagulant should be labeled.

In Daiichi's Phase III ENGAGE AF-TIMI 48 trial, Savaysa showed a favorable balance of risk and benefit only in a patient subgroup with mild renal impairment at the higher of two dose levels (60 mg). Patients with normal kidney function did better on warfarin. ...