Portola has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval to market the investigational treatment betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE).
“If approved, betrixaban would be the first anticoagulant indicated for the prevention of VTE in acute medically ill patients both during hospitalization and for an extended period after the patient returns home,” said John Curnutte, MD, PhD, EVP at Portola.
Betrixaban directly inhibits the activity of Factor Xa – an important validated target in the blood coagulation pathway – to prevent life-threatening thrombosis.
The NDA is based on data from a Phase 3 (APEX) study, which included 7,513 patients and assessed extended-duration anticoagulation with oral betrixaban for 35 – 42 days versus standard-duration injectable enoxaparin for 10+4 days in preventing VTE.
In the primary efficacy subgroup of 3,870 patients with elevated D-dimer levels, the incidence of VTE was reduced for the betrixaban group compared to the enoxaparin group (P=0.054), and additionally in the overall study population (N=7,513; P=0.006). There was no major difference in bleeding observed between the betrixaban and enoxaparin treated groups.
Portola expects a response from the FDA within 60 days regarding whether the NDA is complete and acceptable for filing.
For more information visit Portola.com.