HBsAg-1018 is an investigational adult hepatitis B vaccine that combines recombinant hepatitis B surface antigen with 1018, our proprietary adjuvant. HBsAg-1018 was administered in two doses over one month in clinical trials. Over 10,000 adults have received HBsAg-1018 throughout 11 clinical trials, including three pivotal Phase 3 trials that compared HBsAg-1018 to Engerix-B.
The original Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) in April 2012. FDA issued a Complete Response Letter (CRL) to Dynavax in Feb 2013 requesting an additional clinical trial to increase the safety database. In March of 2016, the BLA was resubmitted to the FDA. The FDA issued a second CRL to Dynavax in November of 2016. See press release here.
CRLs are used by the FDA to communicate that the agency has completed a review cycle of an application and to request additional information for review and approval. We expect a Class 2 designation for the resubmission of the BLA, for which the target review period is six months. We continue to believe that HBsAg-1018 is an approvable product and intends to resubmit the BLA soon. We have streamlined the resources needed to support HEPLISAV-B through an FDA approval decision that is expected to occur in Q3 of 2017.
The content in this section of our website is intended for the scientific community. The compounds and their uses mentioned are investigational and have not been approved by the US Food and Drug Administration. Efficacy and safety have not been established and the information presented should not be construed as a recommendation for use.