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Dynavax Provides Regulatory Update on HEPLISAV-B
PDUFA Date of December 15, 2016, Remains Unchanged
BERKELEY, CA -- (Marketwired) -- 09/04/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].

During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016. The Agency informed Dynavax that the VRBPAC meeting was cancelled and remaining questions will be addressed between Dynavax and the review team via the normal process. The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.

"Our dialogue with the FDA has been very open and productive, and we look forward to providing the review team with any additional information they may need to complete their review," said Eddie Gray, chief executive officer of Dynavax. "We are committed to bringing HEPLISAV-B to market as we believe it offers a better level of protection than the currently available hepatitis B vaccines."

The FDA also confirmed to Dynavax that it will review the overall immunogenicity data from HBV-23, the company's most recent pivotal Phase 3 trial, to support the proposed indication for adults 18 years of age and over. However, the Agency has decided it will not review immunogenicity data related to sub-populations including results in individuals with diabetes because these data were not a direct response to the FDA's February 22, 2013 Complete Response Letter and therefore fell outside of the review time allocated to a Class 2 resubmission. Thus, it was suggested the data should be submitted as a supplemental BLA following approval.

The FDA subsequently issued a public notice on September 2, 2016 of the decision to cancel the previously scheduled VRBPAC meeting. That notice summarized the cancellation decision, the intent to resolve outstanding questions and scheduling of a future VRBPAC meeting, if needed.
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Source: press release, 12/15/16. http://investors.dynavax.com/releaseDetail.cfm?ReleaseID=987707

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Dynavax Announces FDA Advisory Committee Meeting to Review HEPLISAV-B
Advisory Committee Meeting Scheduled for November 16, 2016
BERKELEY, CA -- (Marketwired) -- 08/05/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today 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.
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Source: press release, 8/05/16. http://investors.dynavax.com/releaseDetail.cfm?ReleaseID=983286

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Heplisav Infectious DiseaseHepatitis B infection (prophylaxis)Hepatitis B vaccine1018 ISS and HBsAg

Mechanism of action: Heplisav is an investigational adult hepatitis B vaccine comprised of a first generation 1018 immunostimulatory sequence (1018 ISS) and hepatitis B surface antigen (HBsAg). In Phase 3 trials, HEPLISAV demonstrated earlier and higher protection with fewer doses than currently licensed vaccines.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-11-16

Results: Discontinued