Dynavax Technologies Corporation announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.
"The upcoming VBRPAC meeting is the next step towards our goal of obtaining regulatory approval for HEPLISAV-B and we are prepared for it," said Eddie Gray, chief executive officer of Dynavax. "The company looks forward to discussing HEPLISAV-B with the advisory committee and continuing to work closely with the FDA through the review process."
The VRBPAC reviews and evaluates data regarding the safety, efficacy, and appropriate use of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.
