Dynavax secures EC marketing authorisation for hepatitis B vaccine

Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.

Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.

The vaccine is used for the active immunisation against hepatitis B virus infection (HBV), which is caused by all known subtypes of hepatitis B virus in adults aged 18 years and above.

Heplisav B combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to improve the immune response.

The approval from EC follows the recommendation for marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

It was based on the positive benefit-risk for the vaccine demonstrated by the safety and immunogenicity results of three Phase III clinical trials.

Dynavax CEO Ryan Spencer said: “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.

“With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

“We are pleased that HEPLISAV B has received this latest approval and look forward its launch in Europe expected later this year.”

As per the EC marketing authorisation approval, Heplisav B can be sold in all EU as well as EEA-European Free Trade Association (EFTA) states including Norway, Iceland and Liechtenstein.

The company stated that the new vaccine is now approved in the US and EU.