Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.
The company said that the resubmission includes supplemental information primarily related to manufacturing, as requested by the FDA in a complete response letter (CRL) issued to Portola in August 2016.
AndexXa, an FDA-designated Breakthrough Therapy, 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 to address uncontrolled or life-threatening bleeding. In the U.S., in 2016 approximately 90,000 patients treated with oral Factor Xa inhibitors were admitted to the hospital due to bleeding. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 U.S. patients could benefit from an antidote annually. Currently, there are no approved Factor Xa inhibitor antidotes, the company said.