FDA to review investigational hepatitis B vaccine

pharmafile | April 1, 2016 | News story | Medical Communications, Research and Development dynavax, hepatitis B, vaccines 

Dynavax Technologies (NASDAQ: DVAX) says the FDA has accepted for review the company’s investigational adult hepatitis B vaccine, HEPLISAV-B. The FDA has set a date of September 15, 2016 to make a final decision.

The HEPLISAV-B vaccine performed well in clinical trials, with results showing that two doses of the vaccine given one month apart provides significantly higher rates of protection with an equivalent safety profile compared to three doses of GSK’s Engerix-B, a currently marketed hepatitis B vaccine that is administered over six months.

In late-stage trials, HEPLISAV-B achieved peak seroprotection rates of 95.7%, compared with 79.5% for Engerix-B. The vaccine was also tested in diabetes patients, and provided provided seroprotection rates of 90% versus 65.1% for Engerix-B.

 “This filing is another important step toward our goal of bringing HEPLISAV-B to market to protect adults against hepatitis B,” says Eddie Gray, chief executive of 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.”

Hepatitis B is a chronic disease for which there is currently no cure, making effective vaccination all the more important. Currently-available vaccines, however, are limited by slow onset of protection; poor protection in populations that are hypo-responders; and poor compliance. Dynavax says that in in certain locations, only 30% of people receive all three doses required for the current vaccine to work.

“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,” says Robert Janssen, 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.”

Joel Levy

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