Dynavax to introduce new hepatitis B vaccine

BERKELEY, Calif. — Dynavax Technologies last week announced that the U.S. Food and Drug Administration has approved Heplisav-B 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.



"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," stated William Schaffner, professor of Preventive Medicine, 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."



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.



"HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization," added Eddie Gray, CEO Dynavax. "We expect that [Heplisav-B] will become an essential tool in the public health community's fight to prevent hepatitis B, and we look forward to making Heplisav-B available to clinicians and their adult patients."



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.