Dynavax Wins FDA Approval for Hep B Vaccine

Dynavax Technologies announced on Nov. 9, 2017 that FDA approved its hepatitis B vaccine, Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)], for preventing infection in adults caused by all known subtypes of hepatitis B virus. The product is the first new hep B vaccine to be approved in the United States in more than 25 years and the only two-dose one available for adults, according to the company. The current hep B vaccine regimens require three shots over a six-month period.

"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, Vanderbilt University Medical Center, in a company press release. "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."

Dynavax expects to commercially launch the vaccine in the US in the first quarter of 2018. The company has been building a commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.

The approval comes three months after FDA delayed the initial Prescription Drug User Fee Act date scheduled on Aug. 10, 2017 because it needed further detailed information about the company’s post-marketing study for the vaccine, particularly pertaining to myocardial infarction.

Source: Dynavax Technologies