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news.The Food and Drug Administration (FDA) has accepted Dynavax Technologies' heplisav biologics license application (BLA) for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.
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The company expects to submit European marketing authorization application (MAA) for Heplisav in the third quarter of 2012.
Upon approval of the Heplisav BLA, Dynavax also considers submitting a supplemental BLA for an indication in patients with chronic kidney disease.
Dynavax president and chief medical officer Tyler Martin said the FDA has established 24 February 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," Martin added.