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
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