Dynavax re-files BLA at FDA for Heplisav-B vaccine against Hepatitis B.

Dynavax Technologies Corporation announced that the FDA has accepted for review the Biologics License Application (BLA) for Hepilisav-B, the company's vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date.

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 III 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.