The Food and Drug Administration (FDA) has accepted for review the BLA resubmission for AndexXa (andexanet alfa; Portola) for the reversal of the anticoagulant effects of Factor Xa inhibitors in patients experiencing uncontrolled or life-threatening bleeding.

The BLA resubmission includes supplemental data, as requested by the FDA last year, relating to analytics and manufacturing. The agency has set an action target date of February 2, 2018 to make a decision on the BLA. 

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AndexXa is a recombinant, modified human Factor Xa molecule designed to act as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. The binding of Factor Xa inhibitors to Factor Xa is inhibited, thereby allowing for the restoration of normal hemostatic processes.

Portola is developing AndexXa as the first antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity.

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