Daiichi Sankyo moves Factor Xa drug to Ph III

Japan's Daiichi Sankyo has moved edoxaban into Phase III clinical trials, making it the only Factor Xa inhibitor in a dose-ranging study  conducted in the treatment of atrial fibrillation.

In the new multicenter, double-blind, randomized study, around 16,500  patients will be assigned to one of three treatment groups: 30mg  edoxaban once daily, 60mg edoxaban once daily and warfarin. Patients in  the control arm will receive warfarin once a day, with the dosage  adjusted so that the coagulation parameters lie within a certain target  range.

Edoxaban will be compared to warfarin with regard to the prevention of  strokes and systemic embolic events. The frequency of occurrence of  severe, and clinically-significant, non-severe bleedings will be used as  the primary safety end point. Daiichi expects the study to conclude in  the first half of 2012.