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Heplisav-B Approval Status

  • FDA approved: No
  • Brand name: Heplisav-B
  • Generic name: hepatitis b adult vaccine
  • Company: Dynavax Technologies Corporation
  • Treatment for: Hepatitis B Prevention

Heplisav-B (hepatitis b adult vaccine) is an investigational vaccine intended for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

In November 2016, Dynavax Technologies Corporation 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 Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection.

The CRL seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments.

Development Status and FDA Approval Process for Heplisav-B

DateArticle
Nov 14, 2016Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B
Oct  4, 2016Dynavax Provides Regulatory Update on Heplisav-B
Jun 10, 2013Dynavax Reports Feedback From FDA Meeting Regarding Heplisav Biologic License Application
Feb 25, 2013Dynavax Receives FDA Complete Response Letter on Heplisav Biologic License Application
Nov 16, 2012Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav
Aug 29, 2012Dynavax Announces FDA Advisory Committee to Review Heplisav
Jun 27, 2012Dynavax Announces FDA Acceptance of Heplisav BLA
Apr 27, 2012Dynavax Reports Heplisav BLA Submission

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