Policy & Regulation
Dynavax Technologies' HEPLISAV B receives European Commission Marketing Authorisation
22 February 2021 -

Dynavax Technologies Corporation (Nasdaq: DVAX), a United States-based biopharmaceutical company, announced on Friday that it has received Marketing Authorisation for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) from the European Commission.

The product is intended for the active immunisation against hepatitis B virus (HBV) infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

The product received approval following the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company's Marketing Authorisation Application. The approval was based on the positive benefit-risk for HEPLISAV B as showcased by the safety and immunogenicity results of three Phase three clinical trials.