FDA advises review date for Hepislav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] treatment for Hepatitis B.-Dynavax Technologies

Dynavax Technologies Corporation (DVAX) announced today that the FDA has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review Hepislav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the Hepislav-B Prescription Drug User Fee Act (PDUFA) date of August 10, 2017 solely as a function of meeting logistics.

The PDUFA date remains unchanged. The FDA will communicate specific questions for the VRBPAC to address closer to the meeting date, and will post a draft agenda and draft questions on its website 48 hours prior to the meeting. Hepislav-B is the company's vaccine candidate for immunization against hepatitis B infection in adults ages 18 years of age and older.