Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine.
In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines.
Dynavax president and chief medical officer Tyler Martin said the final document consists of 305 volumes, and the expansion of the indicated age group following the pre-BLA meeting required complete rewrites of the clinical summaries.
Dynavax has requested priority review for HEPLISAV, pursuing an indication for immunization against infection caused hepatitis B virus in adults 18 through 70 years of age.
The company expects to submit a European marketing authorization application for HEPLISAV in the third quarter of 2012.
Dynavax plans to submit a supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with chronic kidney disease, upon the approval of the initial HEPLISAV BLA.
