The European Medicines Agency (EMA) has accepted to review the Dynavax Technologies Marketing Authorization Application (MAA) for Heplisav.
Heplisav is indicated for immunization against infection caused by all known subtypes of hepatitis B virus in people aged 18 through 70 years of age and in patients with chronic kidney disease.
MAA acceptance confirms that the submission is sufficiently complete to permit a substantive review by the EMA.
Dynavax president and chief medical officer Tyler Martin said the acceptance marks the initiation of the regulatory review for Heplisav in Europe.
"We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium," Martin added.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/ema-to-review-dynax-heplisav-marketing-authorization-application-230812
