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# CBER Accepts Portola Anticoagulation Reversal BLA
- URL: https://www.fdaweb.com/cber-accepts-portola-anticoagulation-reversal-bla/
- Published: 2016-02-18T12:00:00.000Z
- Updated: 2026-09-15T02:36:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134821

> CBER has accepted for priority review a Portola Pharmaceuticals BLA for andexanet alfa, indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The user fee review target date is 8/17\. Portola says the therapy should be used to reverse anticoagulation, such as in life-threatening or uncontrolled bleeding or for emergency surgery and urgent procedures.  
>  
> The submission is based on data from the company’s ANNEXA (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) studies. It also included limited efficacy and safety data from initial patients enrolled in anongoing Phase 4 ANNEXA-4 study, an open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban and who present to the hospital with an acute major bleed.