Dynavax gains FDA approval for hepatitis B vaccine Heplisav-B

Dynavax Technologies announced that the FDA approved its vaccine Heplisav-B for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. The company noted that the product "is the first new hepatitis B vaccine in the [US] in more than 25 years and the only two-dose hepatitis B vaccine for adults."

According to Dynavax, approval of Heplisav-B was based on data from three late-stage studies that included nearly 10 000 patients who received the vaccine. The trials compared Heplisav-B administered in two doses over one month to GlaxoSmithKline's Engerix-B administered in three doses over a six-month schedule. Results from one of the studies showed that Heplisav-B had a significantly higher rate of protection of 95 percent compared with 81 percent for Engerix-B.

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In August, the FDA delayed a final decision regarding the approval of Heplisav-B after requesting additional information regarding its post-marketing study for the vaccine. The decision came after an FDA advisory panel voted the previous month in favour of approval of Heplisav-B for use in adults. The regulator had declined to approve Heplisav-B in 2016, 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.

According to Dynavax, it expects to commercially launch Heplisav-B in the US in the first quarter of 2018. Commenting on the approval, RBC Capital Markets analyst Matthew Eckler said "our read of the label looks like a best-case scenario, with no red flags around safety." Eckler added "given Hepislav's superior efficacy and convenience profile, we continue to see potential to grow the current hep B vaccine market…through increased compliance, premium pricing and the capture of adult diabetic population, resulting in $300 million projected peak revenue."

Heplisav-B combines hepatitis B surface antigen with Dynavax's Toll-like receptor agonist to enhance the immune response.

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