Portola to present on preclinical study of andexanet alfa
The study evaluated the activity of andexanet alfa in reversing anticoagulation and reducing bleeding in a validated animal model using Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban as the anticoagulant.
The name of the presentation is Andexanet alfa reverses edoxaban-induced anticoagulation in a rabbit
liver laceration model of acute bleeding (poster No. P3088)
Polly Pine, senior director of pharmacology at Portola Pharmaceuticals, will be the presenting author. The presentation will take place at the Moderated Poster Station.
Previously, Portola conducted a successful Phase 2 proof-of concept study to evaluate andexanet alfa as an antidote for edoxaban in healthy volunteers. Currently, Portola is evaluating the antidote in two randomized, placebo-controlled Phase 3 ANNEXA registration studies with apixaban and rivaroxaban and in a Phase 4 confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed.
Portola expects to submit a Biologics License Application for andexanet alfa to the Federal Drug Administration under an Accelerated Approval pathway at the end of 2015.