Dynavax HEPLISAV-B recommended by EMA committee for marketing approval to treat hepatitis B virus infection

Dynavax Technologies Corporation, a biopharmaceutical company, announced that the ecu 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 selling authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B viral infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years aged and older. The CHMP recommendation was supported the assessment of HEPLISAV-B demonstrated by the security and immunogenicity results from three phase 3 clinical trials and post-marketing safety results.

“Hepatitis B may be a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it are often prevented with effective vaccination,” commented Ryan Spencer, chief military officer of Dynavax. “With a regimen of only two doses in only one-month, HEPLISAV-B provides a singular opportunity to deal with known challenges with patient compliance, while delivering faster and better rates of seroprotection compared to the three dose regimen over 6 months for the comparator vaccine. The positive CHMP opinion is a crucial step to extending the advantages of HEPLISAV-B beyond the us , where it had been approved in 2017.”

In the European Union (EU), HEPLISAV-B isn’t yet approved. Under the EU regulatory process, the ecu Commission will now review the CHMP recommendation and therefore the final judgment on Marketing Authorization is predicted within the half-moon of 2021. If approved by the ecu Commission, Dynavax would receive marketing authorization for HEPLISAV-B altogether EU Member States.

Hepatitis B may be a viral disease of the liver which will become chronic and cause cirrhosis, cancer of the liver and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the increase . there’s no cure for hepatitis B , but effective vaccination can prevent the disease. In adults, hepatitis B is spread through contact with infected blood and thru unprotected sex with an infected person.

HEPLISAV-B is an adult hepatitis B vaccine that mixes hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to reinforce the immune reaction . Dynavax has worldwide commercial rights to HEPLISAV-B.

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