CHMP positive for Heplisav B for the active immunization against hepatitis B virus infection.- Dynavax Technologies

Dynavax Technologies Corporation has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for Heplisav B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of Heplisav-B demonstrated by the safety and immunogenicity results from three Phase III clinical trials and post-marketing safety results.