FDA issues Complete Response Letter to Portola Pharma relating to AndexXa (andexanet alfa) antidote for Factor Xa inhibitors.

Portola Pharmaceuticals Inc. announced that it has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor Xa inhibitors.

In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola�s post-marketing commitments that recently were submitted.