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FDA Advisory Committee Vote in Favor of Dynavax's Hepatitis B Vaccine

The Centers for Disease Control and Prevention (CDC) estimates that 850,000 individuals living in the United States are living with chronic hepatitis B (HBV). Incidence of HBV continues to increase, and there is still no cure for the disease.

Luckily, a new tool to fight hepatitis B may be available in near future, pending approval by the US Food and Drug Administration (FDA). The tool in question? A hepatitis B vaccine called HEPLISAV-B.

Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted favorably to support the presented safety data of the potential hepatitis B treatment.

In a 12-1 vote (with 3 committee member abstentions), the VRBPAC favored that the investigational treatment's safety data supported licensure for hepatitis B infection immunization in adults 18 years of age or older.

The vote proceeds a 13-1 decision to support the potential vaccine's immunogenicity, based on data from phase 3 clinical trials. Though the committee's vote of approval does not play an immediate role in Dynavax Technologies' application for new drug licensing, it could serve as dependable advisory for the FDA.

Eddie Gray, Dynavax chief executive officer, said he believes the vaccine will become an "important new tool in the fight against hepatitis B," pending FDA approval.

"Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection," Gray said. "In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review."

There are currently 2 FDA-approved single-antigen hepatitis B vaccinations on the market: ENGERIX-B and RECOMBIVAX HB; there are also 3 combination vaccines: PEDIARIX, TWINRIX, and COMVAX. HEPLISAV-B reported favorable marks for its lighter use, which is two doses every month compared with the other vaccines that are administered in 3 doses over a 6-month schedule. Despite this benefit, HEPLISAV-B was denied its marketing application twice in the past 3 years.

If the vaccine receives FDA approval, Dynavax intends to commercially launch HEPLISAV-B in the United States in early 2018.
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