Tuesday 6/20/17- Dynavax
Technologies (DVAX) $9.25.
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
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."
What They Do: Dynavax is a clinical-stage immunology company focused on
leveraging the power of the body's innate and adaptive immune responses
through toll-like receptor (TLR) stimulation.
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