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Portola resubmits US FDA biologics license application for AndexXa

Portola Pharmaceuticals Inc. resubmitted its biologics license application for AndexXa, a reversal agent for Factor Xa inhibitors, to the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.

The resubmission includes supplemental information primarily related to manufacturing, as requested by the FDA in a complete response letter issued to Portola in August 2016.

AndexXa is a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor. The drug has a breakthrough therapy designation from the FDA.