Daiichi Sankyo has reported promising late-stage data which shows its investigational anticoagulant edoxaban performed better than Sanofi-Aventis' Lovenox in preventing venous thromboembolic events in patients following total hip replacement surgery.
The Phase III STARS J-V study, which was presented at the American Society of Hematology meeting in Orlando, edoxaban compared with Lovenox (enoxaparin) in patients undergoing THR in Japan. Some 610 patients received either 30 mg of the Japanese drugmaker's once-daily oral, direct factor Xa inhibitor or subcutaneous injection of enoxaparin equivalent to 20 mg twice-daily for 11 to 14 days.
The data showed that asymptomatic deep vein thrombosis occurred in 2.4% of patients receiving edoxaban compared with 6.9% for those on Lovenox, ie a relative risk reduction of 65.7%. There were no pulmonary embolism events observed in either treatment group and there was no statistically significant difference in bleeding.
In terms of potential liver damage, elevations greater than three times the upper limit of the normal range of serum aminotransferase levels occurred in 2.6% of patients taking edoxaban compared with 10% of those taking enoxaparin.
In March 2010, Daiichi Sankyo submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan seeking approval of edoxaban for the prevention of VTE after major orthopaedic surgery. However, the most lucrative indication if the drug is approved will be stroke and a week ago, the Tokyo-based group noted that it has completed enrollment into a global Phase III study, evaluating two doses of edoxaban compared with warfarin, in the prevention of stroke and systemic embolic events in patients with atrial fibrillation.
That trial will be the largest AF outcomes study ever undertaken, said Daiichi Sankyo's head of pharma development, Glenn Gormley. It will involve 21,107 subjects at nearly 1,400 clinical trial sites.