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Dynavax Announces FDA Advisory Committee Vote in Favor of HEPLISAV-B(TM)

BERKELEY, CA--(Marketwired - July 28, 2017) - Dynavax Technologies Corporation (DVAX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that the safety data for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] support licensure for immunization against hepatitis B infection in adults 18 years of age and older. Three members of the panel abstained. Additionally, the Committee provided commentary on the design of Dynavax's proposed post-marketing pharmacovigilance plan for HEPLISAV-B. The FDA did not ask this VRBPAC panel to vote on the immunogenicity of HEPLISAV-B. A prior VRBPAC panel voted 13 to 1 that the data from Phase 3 clinical trials supports the immunogenicity of HEPLISAV-B.

"We are encouraged by the committee's positive vote in favor of HEPLISAV-B, which we believe will become an important new tool in the fight against hepatitis B infection if approved by the FDA," said Eddie Gray, chief executive officer of Dynavax. "Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection. 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."

The incidence of hepatitis B in the U.S. is increasingi and there is no cure for the disease. Therefore, disease prevention through effective vaccination is critical to reducing its spread. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. The HEPLISAV-B regimen is two doses over one month. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults...


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