BRIEF—Dynavax gains British marketing authorization for Heplisav B

US immunotherapy specialist Dynavax Technologies announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its 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 approval was based on the positive benefit-risk for Heplisav as demonstrated by the safety and immunogenicity results of three Phase III clinical trials. The approval was issued to Dynavax' affiliate Dynavax GmbH via the European Commission Decision Procedure (ECDRP).

"Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it can be prevented with effective vaccination," commented Ryan Spencer, chief executive of Dynavax.