ARTICLE | Clinical News

Portola reports additional Phase IIIb/IV data of Factor Xa inhibitor antidote AndexXa

March 23, 2018 5:22 PM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported data from 228 patients with Factor Xa inhibitor-associated acute major bleeding in the Phase IIIb/IV ANNEXA-4 trial showing that AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) led to “excellent or good” hemostasis, defined as stoppage of bleeding, within 12 hours of infusion in 83% of patients. Portola reported a thrombotic event rate of 11% and a mortality rate of 12%, which the company said were "within the range expected in this population given the severity of the bleeding, their advanced age and underlying thrombotic risk." Patients received a bolus dose of AndexXa over 30 minutes followed by a two-hour infusion. Data were presented at the American College of Cardiology meeting in Orlando. The company previously reported data from the trial (see BioCentury, Sept. 5, 2016).

The open-label, international trial's co-primary endpoints are the percent change in anti-Factor Xa activity at two hours and assessment of hemostasis over 12 hours following AndexXa infusion...