Dynavax Technologies Corporation (Nasdaq:DVAX), a US-based biopharmaceutical company, announced on Tuesday that it has received Marketing Authorisation in Great Britain from the nation's Medicines and Healthcare products Regulatory Agency (MHRA) for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Dynavax received approval based on the positive benefit-risk for HEPLISAV B as showcased by the safety and immunogenicity results of three Phase three clinical trials. The approval was issued to Dynavax's affiliate Dynavax GmbH via the European Commission Decision Reliance Procedure (ECDRP).
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to enhance the immune response.
Dynavax has worldwide commercial rights to HEPLISAV-B.
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