The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (Committee) voted 13 to one that Dynavax Technologies' Heplisav data adequately demonstrated immunogenicity. Additionally, the Committee voted eight to five with one abstention that there was insufficient data to adequately support the safety of Heplisav.
Now that Dynavax has received the Committee's input and vote, the company will continue working with the FDA as it completes its review of the Heplisav application. The scheduled Prescription Drug User Fee Act (PDUFA) date for Heplisav is February 24, 2013.
Heplisav is an investigational adult hepatitis B vaccine for which US and European licensure applications have been accepted for review by the FDA and the EMA. The PDUFA date for completion of the FDA review of the Heplisav Biologic License Application (BLA) is February 24, 2013. Dynavax has worldwide commercial rights to Heplisav. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases.