Dynavax Announces FDA Acceptance of HEPLISAV(TM) BLA
BERKELEY, CA, Jun 26, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced that the Food and Drug Administration (FDA)
has accepted for review the U.S. Biologics License Application (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.
Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "The FDA
has established February 24, 2013, as the PDUFA action date. We look forward to
working with the FDA in moving HEPLISAV through the regulatory review process
over the next few months."
The Company anticipates submitting a European Marketing Authorization Application
(MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the HEPLISAV
BLA, Dynavax plans to submit a supplemental BLA for an indication in patients
with chronic kidney disease.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has
been accepted for review by the FDA and a European Marketing Authorization
Application (MAA) is expected to be submitted in the third quarter of 2012. In
Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer
doses than currently licensed vaccines. Dynavax 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.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase
3 investigational adult hepatitis B vaccine designed to provide higher and
earlier protection with fewer doses than currently licensed vaccines. For more
information visit dynavax.com. |
