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Heplisav-B Wins FDA Approval for Hepatitis B Prevention in Adults

First new hepatitis B vaccine in 25 years requires only two doses

Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted], Dynavax Technologies Corporation) has received FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age 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.

Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20% nationally. Hepatitis B can be prevented through effective vaccination. Current hepatitis B vaccines require three shots over a six-month period, but almost half of adults fail to complete the series within one year.

"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, MD, Professor of Preventive Medicine at Vanderbilt University Medical Center. "Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States."

Heplisav-B combines hepatitis B surface antigen with Dynavax's proprietary Toll-like receptor 9 agonist to enhance the immune response. The approval of Heplisav-B was based on data from three phase 3 noninferiority trials of nearly 10,000 adults who received Heplisav-B. The pivotal studies compared Heplisav-B administered in two doses over one month to Engerix-B (GlaxoSmithKline) 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%).

Dynavax expects to commercially launch Heplisav-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than human immunodeficiency virus, and transmission is on the rise. In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas. Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults 19 to 59 years of age with diabetes as soon as possible after their diagnosis, and for people 60 and older with diabetes at their physician's discretion.

Source: Dynavax; November 9, 2017.

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