Medication Monitor



Generic Name (Trade Name—Company)
Notes
November 14, 2017

Hepatitis B vaccine, recombinant (adjuvanted)

(Heplisav-B—Dynavax)
First and only two-dose vaccine for hepatitis B approved

FDA has approved Heplisav-B, a new hepatitis B vaccine, recombinant (adjuvanted) vaccine to prevent infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. It 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.

Current hepatitis B vaccines require three shots over a 6-month period. However, almost one-half of adults fail to complete the series within 1 year.

Approval was based on data from three Phase III noninferiority trials of nearly 10,000 adult participants who received the vaccine. The pivotal studies compared the Heplisav-B vaccine, administered in two doses over 1 month, to Engerix-B,  administered in three doses over a 6-month schedule. Results from the largest Phase III 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%–39%). The most common systemic reactions were fatigue (11%–17%) and headache (8%–17%).

Dynavax expects to commercially launch Heplisav-B in the United States in the first quarter of 2018.