Posted by Michael Wonder on 29 Mar 2019
Dynavax announces European Medicines Agency accepts marketing authorisation application for Heplisav-B for prevention of hepatitis B in adults
28 March 2019 - Dynavax Technologies today announced that the EMA has accepted the Company’s marketing authorisation application for review of Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
This acceptance follows Dynavax’s submission of the application on March 11 and marks the beginning of the regulatory review process for Heplisav-B in the European Union. The outcome of the review by the EMA is expected next year.
The application for Heplisav-B is based upon the successful outcomes from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received Heplisav-B.
