Dynavax Confirms HEPLISAV Submission Strategies With U.S. FDA and EMA

Dynavax Technologies Corporation DVAX today said that the U.S. Food and Drug Administration had concurred with the company's plan to submit a Biologics License Application for HEPLISAV for persons over 40 years of age, followed by a supplemental BLA for licensure of a specific regimen for vaccinating chronic kidney disease patients against hepatitis B infection at the time the initial application is approved. Dynavax also updated its timeline for the company's first BLA submission saying it expected to submit in the first quarter of 2012. Dynavax also said that the European Medicines Agency has advised the company it could submit the primary endpoint immunogenicity data and associated safety data for the over-40 population as well as the CKD indication as part of the initial Marketing Authorization Application (MAA) and that the outstanding CKD data can be submitted in the course of the application's review. Dynavax confirmed its plan to submit the MAA for European approval after the submission of its BLA in the U.S.