The US Food and Drug Administration (FDA) has accepted for review the US Biologics License Application (BLA) of Dynavax Technologies Corporation's 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.

Tyler Martin, MD, president and chief medical officer, Dynavax 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.

Heplisav is an investigational adult hepatitis B vaccine for which a US 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 III 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.

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases.