Betrixaban

Drug Overview

Betrixaban (Portola Pharmaceuticals) is an oral, once-daily inhibitor of factor Xa that catalyzes conversion of prothrombin to thrombin, preventing thrombosis. Betrixaban is currently in Phase III development in the US and EU for the prevention of venous thromboembolism.

Analyst Outlook

Betrixaban (Portola Pharmaceuticals) failed to demonstrate statistical significance in patients with elevated D-dimer levels in its recent APEX trial results, but results from the other patient cohorts look to be encouraging. Betrixaban may become the first novel oral anticoagulant (NOAC) drug to gain approval for extended treatment of venous thromboembolism (VTE) in acutely ill patients. The APEX trial is evaluating the drug’s superiority over current standard vitamin K antagonist (VKA)/enoxaparin treatment in critically ill patients. Betrixaban has the potential to become the standard of care in this niche market segment. Datamonitor Healthcare believes that upon approval, betrixaban could easily penetrate this segment with minimal competition from other NOAC molecules, owing to its superior clinical properties such as half-life, safety, dosage, and minimal drug interactions in the intended patient population. Development of AndexXa (andexanet alfa; Portola Pharmaceuticals), an in-house antidote, will further help with betrixaban’s adoption among physicians concerned with the lack of a reversal agent.