(By Balaseshan) Dynavax Technologies Corp. (NASDAQ:DVAX) said the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) of its investigational adult hepatitis B vaccine.
The company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012.
Medical Chief Tyler Martin said the FDA has established February 24, 2013, as the PDUFA action date. The company looks forward to working with the FDA in moving HEPLISAV through the regulatory review process over the next few months.
The FDA has accepted for review the U.S. 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.
Upon approval of the HEPLISAV BLA, Dynavax intends to submit a supplemental BLA for an indication in patients with chronic kidney disease.
In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines.
Dynavax has worldwide commercial rights to HEPLISAV. The drug combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
DVAX is trading up 2.17% at $4.24 on Tuesday. The stock has been trading between $1.75 and $5.34 for the past 52 weeks.