FDA approves Dynavax’s HEPLISAV-B™ for the prevention of hepatitis B

Dynavax Technologies Corporation (CA, USA) have announced FDA approval for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. The vaccine will be the first and only two-dose vaccine in the USA for the prevention on Hepatitis B in adults, and the first new hepatitis B vaccine in the USA in over 25 years.

In the USA, current prevention strategies for hepatitis B involve a three-dose vaccination protocol over a 6 month period; however, compliance is a contentious issue as most adults fail to complete the series within 1 year.

“Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections,” commented William Schaffner, Professor of Preventive Medicine (Vanderbilt University Medical Center; TN, USA). “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.”

Three Phase III non-inferiority trials of nearly 10,000 adult participants receiving HEPLISAV-B were conducted, the data of which used as a basis for FDA approval. Studies comparing HEPLISAV-B administered in two doses over 1 month to Engerix-B administered in three doses over a 6-month schedule demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B.

“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,” explained Eddie Gray, Chief Executive Officer (Dynavax). “We would like to thank the many study participants and clinical trial investigators who contributed to the development of HEPLISAV-B. We expect that it 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.

Source: http://investors.dynavax.com/releasedetail.cfm?ReleaseID=1048181