Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases, has submitted a US Biologics Licence Application (BLA) to the Food and Drug Administration (FDA) 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, MD, said, “This submission is a very important milestone for Dynavax. 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. The entire Heplisav team did outstanding work to complete the revisions and submit the BLA ahead of schedule.”
He further added, “We have requested priority review for Heplisav, as we believe it is a significant improvement compared to marketed products. We look forward to working with the FDA on the BLA and to ultimately bringing the benefits of Heplisav to the public.”
The company anticipates submitting a European Marketing Authorization Application (MAA) for Heplisav in the third quarter of 2012. Upon approval of the initial Heplisav BLA, Dynavax plans to submit a supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with chronic kidney disease.
Heplisav is an investigational adult hepatitis B vaccine. 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.