Daiichi-Sankyo begins Phase III for DU-176b for stroke prevention
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Daiichi-Sankyo is moving its Factor Xa inhibitor DU-176b into Phase III to prevent stroke and systemic embolic events in patients with atrial fibrillation. DU-176b will be the third oral, direct Factor Xa inhibitor to reach pivotal trials as companies race to market anticoagulants without warfarin's many complications (1Pharmaceutical Approvals Monthly October 2008, p. 3). Phase II studies showed two doses of DU-176b to be similar to warfarin in the incidence of major and clinically relevant non-major bleeding events, the firm said Dec. 8. The Phase III study will randomize approximately 16,500 patients to either 30 mg or 60 mg of DU-176b once daily or warfarin. The event-driven study has an expected median treatment duration of 24 months and is expected to conclude in 2012