Portola announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) of betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Betrixaban, an investigational oral, once-daily Factor Xa inhibitor, has the potential to be the first anticoagulant approved for in-hospital and extended-duration VTE in high-risk acute medically ill patients. It directly inhibits Factor Xa activity to prevent life-threatening thrombosis. Key properties of betrixaban include a 19–25 hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio to minimize anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce drug-drug interaction risks.
The NDA included data from the Phase 3 multicenter, randomized, active-controlled APEX Study (n=7,513) that evaluated the superiority of extended-duration anticoagulation with oral betrixaban for 35–42 days vs. standard-duration injectable enoxaparin for 10±4 days in preventing VTE in high-risk acute medically ill patients.
Full study findings from the APEX Study and its 3 sub-studies, including a retrospective sub-study that evaluated the potential of betrixaban in reducing the risk of stroke in hospitalized acute medically ill patients, have been published.
The FDA had previously designated betrixaban a Fast Track drug and has set a Prescription Drug User Fee Act (PDUFA) action date of June 24, 2017.
For more information visit Portola.com.