Betrixaban: FXa Inhibitor

Description

  • Oral, once-daily Factor Xa inhibitor anticoagulant that directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis
  • U.S. Food and Drug Administration granted Fast Track designation to betrixaban for extended-duration prevention of venous thromboembolism (VTE; blood clots) in acute medically ill patients (i.e., those who are hospitalized for serious medical conditions, such as heart failure, stroke, infection and pulmonary disease).
  • Has the potential to become the first oral Factor Xa inhibitor anticoagulant approved for hospital-to-home prevention of VTE in acute medically ill patients
  • Portola has worldwide rights to develop and commercialize betrixaban

Clinical Development

APEX Study

Phase 3

  • Pivotal, randomized, double-blind study evaluated the superiority of extended-duration anticoagulation with oral betrixaban (for 35-42 days) compared with standard of care anticoagulation with injectable enoxaparin (for up to 14 days) for the prevention of VTE in acute medically ill patients.
  • Used a biomarker-based design to identify and enroll patients at highest risk of VTE — specifically, those with an elevated blood level of D-dimer (a protein fragment present after a blood clot has developed) and those over age 75.
  • Portola reported topline data from the APEX Study on March 24, 2016. Full data was presented in an oral session at the International Society on Thrombosis and Haemostasis (ISTH) 62nd Annual SSC (Scientific and Standardization Committee) Meeting, on Friday, May 27, 2016, in Montpellier, France.
  • In October, Portola submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.