ARTICLE | Clinical News

Andexanet alfa: Additional Phase III data

December 8, 2014 8:00 AM UTC

Additional data from 33 healthy volunteers ages 50-75 in part 1 of the 2-part, double-blind, U.S. Phase III ANNEXA-A trial showed that a 400 mg IV bolus of andexanet alfa reversed the anticoagulant activity of Eliquis apixaban, the primary endpoint, by about 94% as measured by the mean change in anti-Factor Xa levels from baseline at 2 or 5 minutes after the end of the bolus vs. placebo (p<0.0001). Patients received twice-daily 5 mg Eliquis for 4 days followed by placebo or andexanet alfa on day 4 given 3 hours after the last Eliquis dose. Data were presented at the American Heart Association meeting in Chicago. Portola previously reported that andexanet alfa met the primary endpoint (see BioCentury, Oct. 6). ...