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Will Portola’s Betrixaban Data Pass Muster With FDA?

 
• By Emily Hayes

Portola says that it does not expect it will need to do a second Phase III study to get FDA approval for betrixaban, after missing major endpoint in APEX, but analysts have doubts.

Portola Pharmaceuticals Inc. is hoping to persuade FDA to approve its anticoagulant betrixaban based on the totality of data in its pivotal APEX study of high-risk, acute medically ill patients, even though the drug missed a key endpoint in the trial.

The APEX study tested extended anticoagulation with betrixaban – a Factor Xa inhibitor – against the low molecular weight heparin enoxaparin (Sanofi’s Lovenox and generics), which is given on a shorter-term basis as an injectable, for preventing venous thromboembolism in 7,513 acute medically ill patients, meaning patients hospitalized for conditions like heart failure, stroke, infection and

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