Dynavax Announces European Medicines Agency Accepts Marketing Authorization Application for HEPLISAV-B® for Prevention of Hepatitis B in Adults
This acceptance follows
"The acceptance of the HEPLISAV-B application for review by the EMA signifies an important milestone in our journey to help prevent hepatitis B in adults through vaccination," said
In 2017, the
The MAA for HEPLISAV-B is based upon the successful outcomes from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received HEPLISAV-B. The pivotal studies compared HEPLISAV-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response.
For more information about HEPLISAV-B, visit http://heplisavb.com/.
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.
This press release contains "forward-looking" statements, including statements regarding HEPLISAV-B and the potential timing of an EMA review decision. These statements are subject to a number of risks, including whether the EMA will find the submission to be complete or whether it will seek further information, including the conduct of additional clinical trials; whether it will complete its review of the MAA within the anticipated timeframe; and whether the outcome of its review will be an approval, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
Vice President, Investor Relations & Corporate Communications
Source: Dynavax Technologies Corporation