Daiichi Sankyo reported data from a Phase III trial demonstrating that its once-daily, oral direct factor Xa inhibitor, edoxaban, performed better than enoxaparin sodium in preventing venous thromboembolic events (VTE) in patients following total hip replacement surgery. The investigational drug also reduced the incidence of elevated liver damage markers.
Results from the Stars J-V study were presented at the American Society of Hematology annual meeting. Daiichi Sankyo submitted an NDA to the Japanese regulatory authorities in March requesting approval of the drug for use in the prevention of VTE after major orthopedic surgery.
The multicenter double-dummy Stars J-V trial compared the safety and efficacy of once-daily oral edoxaban with that of twice-daily enoxaparin injection, in 610 total hip-replacement patients treated over 11-14 days. Results showed that asymptomatic deep vein thrombosis occurred in 2.4% of patients receiving edoxaban, and in 6.9% of those treated using enoxaparin. Levels of the liver damage indicator serum aminotransferase increased to three times the upper normal limit in 2.6% of edoxaban patients and in 10% of enoxaparin patients. There were no pulmonary embolism events in either group, and no statistical difference in major and clincially relevant nonmajor bleeding events. No patient in either treatment group suffered intracranial hemorrhage or death.
At the beginning of December Daiichi Sankyo confirmed it had completed enrollment into the global Phase III ENGAGE AF-TIMI 48 clinical study, which is evaluating two doses of once-daily edoxaban, compared with warfarin therapy, in the prevention of stroke and systemic embolic events in patients with atrial fibrillation. The study has enrolled 21,107 patients at nearly 1,400 clinical sites.