The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.

The CRL communicated the FDA’s request to provide additional information primarily related to the manufacturing of AndexXa. Additional data to support the inclusion of enoxaparin and edoxaban in the label was also requested. In addition, the agency also communicated its need to finalize the review of the clinical amendments to the company’s recently submitted post-marketing commitments. 

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There currently is no FDA-approved antidote for Factor Xa inhibitors (eg, apixaban, rivaroxaban, edoxaban, enoxaparin). AndexXa would address an urgent unmet medical need so Portola is committed to working closely with the FDA and resolving the outstanding issues in order to move the drug closer to approval.

AndexXa is an investigational, 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, therefore restoring normal hemostatic processes.

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