Dynavax Announces FDA Advisory Committee Vote in Favor of HEPLISAV-B(TM)
"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
The incidence of hepatitis B in the
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma and death. In the
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase 3 trials, HEPLISAV-B showed higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The most frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine.
This press release contains "forward-looking" statements, including statements regarding HEPLISAV-B and
ii Nelson JC, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents and adults: Results from a Vaccine Safety Datalink study.
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