Dynavax Presents New Efficacy Data on Hepatitis B Vaccine, HEPLISAV-B(TM), in Adults With Type 2 Diabetes at ADA Scientific Sessions - Seite 2

In the total trial population, the rates of adverse events, serious adverse events and deaths were similar between the HEPLISAV-B and Engerix-B groups. All adverse events considered to represent potential immune-mediated disorders were reviewed by an independent, blinded Safety Evaluation and Adjudication Committee, which classified these events as not related to vaccination.

"The hepatitis B virus can spread easily through contact with contaminated medical equipment, such as blood glucose monitors, posing a serious health risk to people living with diabetes," said Rob Janssen, M.D., chief medical officer for Dynavax. "Results of this study show that, with two doses over one month, HEPLISAV-B provided a significantly higher rate of seroprotection in participants with type 2 diabetes than an existing hepatitis B vaccine."

The U.S. Food and Drug Administration has established December 15, 2016, as the Prescription Drug User Fee Act (PDUFA) action date for the HEPLISAV-B Biologics License Application.

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 U.S., the CDC estimates that approximately 20,000 hepatitis B infections continue to occur annually, with the vast majority occurring in adults. There is no cure for hepatitis B, and disease prevention through effective vaccination is critical to reducing the spread of the disease. Currently marketed hepatitis B vaccines are administered in three doses over a six-month schedule. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year. Those who do not complete the series may not be adequately protected against hepatitis B.

About HEPLISAV-B

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 demonstrated higher and earlier protection with fewer doses than Engerix-B, a currently licensed hepatitis B vaccine. HEPLISAV-B was administered in two doses over one month.

The investigational vaccine's safety profile is based on clinical trials that generated safety data from more than 14,000 participants. 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 Engerix-B.