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by Counterflix
Home FDA Status AndexXa
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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 Portolas post-marketing commitments.

Development Status and FDA Approval

Process for AndexXa
Date Article

Aug 18, Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics Lice
2016 Application for AndexXa (andexanet alfa)

Feb 17, 2016 Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA

Dec 18, 2015 Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administrati
Andexanet Alfa

Jun 22, 2015 Portola, Bristol-Myers Squibb and Pfizer Announce Full Results of Second Part of Phase 3
ANNEXA-A for Andexanet Alfa

Nov 17, Statistically Significant Results from the First Part of the Phase 3 ANNEXA-A Studies o
2014 Investigational Andexanet Alfa
Disclaimer: Every effort has been made to ensure that the information provided here is
accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information
contained herein may be time sensitive. This information has been compiled for use by
healthcare practitioners and consumers in the United States. The absence of a warning for a
given drug or combination thereof in no way should be construed to indicate that the drug or
combination is safe, effective or appropriate for any given patient. If you have questions about
the substances you are taking, check with your doctor, nurse or pharmacist.

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by Counterflix

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