New Oral Anticoagulant NDA Granted Priority Review

New Oral Anticoagulant NDA Granted Priority Review
New Oral Anticoagulant NDA Granted Priority Review

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. 

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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. 

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