As there is currently no approved antidote for Factor Xa inhibitors in the EU, we are working diligently to bring IndexXa to patients. The MAA validation is an important milestone toward achieving that goal. Portolas MAA submission is based on data from two Phase 3 ANNEXA studies that evaluated the safety and efficacy of andexanet alfa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers. Results of the ANNEXA studies were published by The New England Journal of Medicine. The MAA also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study. Portola is currently evaluating andexanet alfa in this global, Phase 3b/4 single-arm, open-label study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed. The study is enrolling patients in the United States, Canada and the EU. On August 17, 2016, Portola received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa. The Company plans to meet with the FDA as soon as possible in order to resolve the outstanding questions in the CRL and determine appropriate next steps. The Urgent Need for a Factor Xa Inhibitor Antidote Annually, 1 to 4 percent of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional one percent may require emergency surgery. Commensurate with the increase in the use of Factor Xa inhibitors — for stroke prevention in atrial fibrillation; http://www.theactproject.com/wwwtheactprojectcom5959/2016/08/08/an-associate-degree-is-basically-a-two-year-degree-equivalent-to-the-first-two-years-in-a-bachelor-degree-program/ treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery — the number of hospital admissions due to bleeding associated with these agents continues to grow.
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