Dynavax Submits Heplisav for EU Marketing Authorization

Dynavax looks forward to working with the EMA to progress HEPLISAV toward approval in Europe.

Dynavax Technologies Corporation has submitted a Marketing Authorization Application to the European Medicines Agency pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "This submission is another significant step in the development of HEPLISAV. We look forward to working with the EMA to progress HEPLISAV toward approval in Europe in order to realize our goal that it be available to physicians and patients in Europe and the U.S."