FDA accepts filing of Hepislav ( Dynavax Technologies) vaccine for Hepatitis B

The FDA has accepted for review the biologics license application (BLA) for the Hepatitis B vaccine, Heplisav, from Dynavax Technologies. Hepislav is an immunostimulatory sequence targeting toll-like receptor 9 (TLR9) combined with hepatitis B surface antigen. The FDA set 24 February 2013 as the Prescription Drug User Fee Act action date for Heplisav. The attraction of Hepislav is an easier dosing schedule and its ability to work on the weakened immune systems of older people. Hepislav combines a segment of the hepatitis B virus and a DNA sequence that activates a toll-like receptor, triggering an early immune response.