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ARTICLE | Clinical News

Portola's AndexXa "on track" to meet in Phase IIIb/IV

August 30, 2016 7:00 AM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported interim data from the single-arm, open-label Phase IIIb/IV ANNEXA-4 study of AndexXa andexanet alfa showing 79% of patients achieved excellent or good hemostasis within 12 hours of infusion with the anticoagulant reversal agent. The company said the ongoing open-label study is "on track" to meet its co-primary efficiency endpoints, which are percent change in anti- Factor Xa activity at two hours and hemostasis at 12 hours after infusion.

ANNEXA-4 is evaluating AndexXa in patients who present with an acute major bleed while receiving a Factor Xa inhibitor. Patients receive a bolus dose of AndexXa over 30 minutes followed by a two-hour infusion. ...