Dynavax Technologies Corp. (DVAX) said the European Medicines Agency or EMA has accepted the filing of the Marketing Authorization Application or MAA 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 and in patients with chronic kidney disease. The MAA acceptance confirms that the submission is sufficiently complete to permit a substantive review by the EMA.
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for 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, M.D. The company looks forward to working through the review process with its designated rapporteur from Sweden and co-rapporteur from Belgium.
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