Dynavax Technologies Corp. (DVAX) announced that the U.S. Food and Drug Administration or FDA has informed the company that its Vaccines and Related Biological Products Advisory Committee or VRBPAC is scheduled to discuss Heplisav at its meeting on November 14-15, 2012.
Dynavax said that its Biologic License Application or BLA for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, is currently under review by the FDA. The Prescription Drug User Fee Act or PDUFA date for the FDA to complete its review is February 24, 2013.
Heplisav is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA.
In Phase 3 trials, Heplisav demonstrated higher and earlier protection with fewer doses than currently licensed vaccines.
Dynavax noted that it 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.
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