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Andexxa Approval History

FDA Approved: Yes (First approved May 3, 2018)
Brand name: Andexxa
Generic name: coagulation factor Xa (recombinant), inactivated-zhzo
Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Development History and FDA Approval Process for Andexxa

DateArticle
May  3, 2018Approval FDA Approves Portola Pharmaceuticals’ Andexxa, First and Only Antidote for the Reversal of Factor Xa Inhibitors
Aug 18, 2016Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)
Feb 17, 2016Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA
Dec 18, 2015Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa
Jun 22, 2015Portola, Bristol-Myers Squibb and Pfizer Announce Full Results of Second Part of Phase 3 ANNEXA-A for Andexanet Alfa
Nov 17, 2014Statistically Significant Results from the First Part of the Phase 3 ANNEXA™-A Studies of Investigational Andexanet Alfa

Further information

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