AndexXa andexanet alfa: Interim Phase IIIb/IV data

Interim data from 47 evaluable patients with Factor Xa inhibitor-associated acute major bleeding in the open-label, international Phase IIIb/IV ANNEXA-4 trial showed that AndexXa led to “excellent or good” hemostasis, defined as stoppage of bleeding, within 12 hours of infusion in 79% of patients. Patients received a bolus dose of AndexXa over 30 minutes followed by a 2-hour infusion. Additionally, AndexXa reduced median anti-Factor Xa activity from baseline by 89% and 93% in patients receiving Xarelto rivaroxaban and Eliquis apixaban, respectively. Of 67 evaluable patients, 12 reported thrombotic events within 30 days of receiving AndexXa, with 10 patient deaths. Portola said the events “occurred within the range expected” in the patient population. The trial has enrolled >130 of a planned 270 patients. The company said the trial is “on track” to meet its co-primary endpoints. Data were published in The New England Journal of Medicine and presented at the European Society of Cardiology meeting in Rome. ...