Posted by Michael Wonder on 10 Nov 2017
Dynavax announces FDA approval of Heplisav-B for prevention of hepatitis B in adults
9 November 2017 - First and only two-dose vaccine in United States for prevention of hepatitis B in adults.
Dynavax Technologies today announced that the U.S. FDA has approved Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
The approval of Heplisav-B was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received Heplisav-B. The pivotal studies compared Heplisav-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis of 961 participants with Type 2 diabetes, Heplisav-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).
