FDA advisory panel says safety data support approval of Dynavax's hepatitis B vaccine Heplisav-B

Dynavax Technologies announced Friday that an FDA advisory panel voted 12 to 1 that safety data support approval of the hepatitis B vaccine Heplisav-B for use in adults. The regulator is expected to issue a final decision regarding clearance of Heplisav-B by August 10.

In documents released ahead of the advisory panel meeting, FDA reviewers agreed that Heplisav-B is effective, but noted that rates of deaths and serious cardiac events were higher in patients who received the immunisation than in those treated with another vaccine. Dynavax said that the latest advisory panel did not vote on the immunogenicity of Heplisav-B, as a committee voted 13 to 1 in 2012 that data from Phase III trials supports the immunogenicity of the vaccine.

In November last year, the FDA declined to approve Heplisav-B, in part due to a numerical imbalance in the incidence of cardiovascular events between the arms of one clinical study, while the therapy was previously rejected over safety issues.

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CEO Eddie Gray remarked that "clinical studies of Heplisav-B have shown that the vaccine provides increased rates of seroprotection," adding that the two-dose regimen over one month also "offers the potential to increase patient compliance." Heplisav-B combines hepatitis B surface antigen with a Toll-like receptor 9 agonist to enhance the immune response.

Commenting on the panel vote, William Blair analyst Katherine Xu estimated that Heplisav-B could eventually amass $650 million a year in peak revenue if approved. The analyst added that the treatment could become the standard of care given its easier dosing schedule compared to GlaxoSmithKline's Engerix-B, which is administered as three doses over a six-month schedule.

Dynavax noted that if approved, it will seek guidance from the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices during its October 2017 meeting. The company added that it hopes to launch the vaccine in the US early next year either on its own or through a commercial partner.

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