US FDA advisory panel backs Daiichi Sankyo’s Savaysa for stroke risk and SEE

A US Food and Drug advisory panel has voted in favor of the use of Japanese pharma major Daiichi Sankyo’s (TYO: 4568) Savaysa (edoxaban), but there was some ambivalence over labelling.

The agency’s Cardiovascular and Renal Drugs Advisory Committee voted nine to one to recommend approval of once-daily Savaysa 60mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Panel members, however, discussed future trials that would adjust the dose based on renal function or, possibly, limiting the indication to patients with impaired renal function.

Ahead of the advisory committee’s briefing notes from FDA staff recommended limiting use of the drug to patients with renal impairment, citing subgroup data showing that the 60mg dose was "almost significantly worse" than warfarin in patients with normal kidney function.