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AndexXa Approval Status

  • FDA approved: No
  • Brand name: AndexXa
  • Generic name: andexanet alfa
  • Company: Portola Pharmaceuticals, Inc.
  • Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

AndexXa (andexanet alfa) is a recombinant protein designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors.

In August 2016, Portola Pharmaceuticals Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). In the CRL, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola’s post-marketing commitments.

Development Status and FDA Approval Process for AndexXa

DateArticle
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

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