Dynavax Technologies Corp. (DVAX) on Tuesday announced that the Food and Drug Administration has accepted for review the U.S. Biologics License Application 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, 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 expects to submit a European Marketing Authorization Application 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.
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