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news.The US Food and Drug Administration (FDA) has accepted for review Dynavax Technologies' Biologics License Application (BLA) for HEPLISAV-B, the company's vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older.
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The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date.
"This filing is another important step toward our goal of bringing HEPLISAV-B to market to protect adults against hepatitis B," said Eddie Gray, chief executive officer for Dynavax.
"We will continue to work closely with the FDA over the coming months in order to achieve HEPLISAV-B approval in the third quarter of 2016."
The HEPLISAV-B BLA is based on positive immunogenicity results from clinical trials that have generated safety data in more than 10,000 participants. Results of these trials showed that two doses of HEPLISAV-B given one month apart provides significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B, a currently marketed hepatitis B vaccine that is administered over six months.
In Phase 3 studies across all participants, HEPLISAV-B achieved peak seroprotection rates of 95.7 percent compared with 79.5 percent for Engerix-B. Additionally, in more than 1,100 participants with diabetes, HEPLISAV-B provided seroprotection rates of 90 percent compared to 65.1 percent for Engerix-B.
"Adult hepatitis B infection remains an important public health concern. If approved, HEPLISAV-B will represent the first advance in hepatitis B immunization in the United States in more than 25 years and will offer rapid protection from hepatitis B after only two doses in just one month," said Robert Janssen, M.D., chief medical officer and vice president, clinical development for Dynavax.
"We believe HEPLISAV-B will provide a significant real-world improvement over currently marketed hepatitis B vaccines."
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 United States, the Centers for Disease Control and Prevention estimates that 19,000 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 more effective vaccines is critical to reducing the spread of the disease.
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 a currently licensed hepatitis B vaccine.
HEPLISAV-B is administered in two doses over one-month, offering rapid protection. 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.
Dynavax has worldwide commercial rights to HEPLISAV-B.