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FDA Gives ‘Thumbs Down’ to Hepatitis B Vaccine, Heplisav

Agency asks for more safety data (Feb. 25)

The FDA has turned down the Biologic License Application (BLA) for Heplisav (Dynavax Technologies), an investigational adult hepatitis B vaccine.

In its response letter, the agency specified that the indication in adults 18 to 70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continued to express concern that novel adjuvants may cause rare autoimmune events. However, the agency indicated that it is willing to continue discussions regarding a more restricted use of Heplisav.

Further, the FDA requested additional data from the manufacturer’s process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product.

The BLA for Heplisav was accepted for review by the FDA in June 2012. On November 15, 2012, the FDA's Vaccines and Related Biological Products Advisory Committee voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of Heplisav, although the committee voted 13 to 1 that data for the vaccine adequately demonstrated immunogenicity.

Heplisav combines hepatitis B surface antigen with a Toll-like receptor 9 (TLR 9) agonist to enhance the immune response. TLRs are a class of proteins that play a key role in the innate immune system.

Source: Dynavax Technologies; February 25, 2013.

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