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Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016

BERKELEY, CA, Apr 27, 2016 (Marketwired via COMTEX) -- Dynavax Technologies Corporation DVAX, -2.92% today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the Biologics License Application (BLA) for HEPLISAV-B(TM), Dynavax's investigational vaccine for immunization of adults against hepatitis B infection. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) action date for HEPLISAV-B has been extended by three months to December 15, 2016.

On April 8, in response to an FDA request, Dynavax submitted individual trial data sets that had been provided as integrated data in the March 2016 BLA resubmission. FDA then determined that the addition of these large data sets represented a major amendment to the BLA and thus extended the PDUFA action date to allow for a full review.

The HEPLISAV-B BLA is based on results from clinical trials that have generated data in more than 14,000 total participants.

"We appreciate the commitment of the FDA staff to conduct a complete review of all of the data supporting our BLA and we remain committed to working closely with them over the coming months in order to achieve HEPLISAV-B approval in 2016," said Eddie Gray, chief executive officer of Dynavax.


HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B...