The European Medicines Agency (EMA) has accepted Dynavax Technologies' Marketing Authorization Application (MAA) filing for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus (HBV) in adults 18 through 70 years of age and in patients with chronic kidney disease (CKD).
Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA.
"This milestone marks the initiation of the regulatory review for Heplisav, in Europe," said Dynavax president and chief medical officer, Tyler Martin, MD. “We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium."
Heplisav, is an investigational adult hepatitis B vaccine for which a US BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. 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.