EMA accepts Dynavax' filing for hep B drug Heplisav

US biotech firm Dynavax Technologies (Nasdaq: DVAX) revealed yesterday that the European Medicines Agency has accepted the filing of the Marketing Authorization Application 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.

Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA. Dynavax’ US Biological License Application for the product has already been accepted by the Food and Drug Administration, the company said.

"This milestone marks the initiation of the regulatory review for Heplisav in Europe," said Dynavax president and chief medical officer, Tyler Martin, adding:"We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium."