Dynavax withdraws marketing application for hepatitis B vaccine
HEPLISAV is an investigational adult hepatitis B vaccine that combines a proprietary toll-like receptor 9 agonist with a hepatitis B surface antigen to enhance the human immune response. The European Medicines Agency said the current HEPLISAV safety database is considered to be too small to rule out a risk of less common serious adverse events. The EMA included its concerns in a day 180 list of outstanding issues.
Dynavax, which has worldwide commercial rights to HEPLISAV, said it chose to withdraw the application because the required timeframe under the MAA procedure was not long enough to permit the company to collect the required clinical data. Dynavax plans to start an additional HEPLISAV clinical trial soon.
The trial, called HBV-23, is meant to provide a safety database that will be sufficient to support vaccine licensure.
HEPLISAV is Dynavax's lead product candidate. Dynavax discovers and develops novel therapeutics and vaccines in the areas of inflammatory and infectious diseases and oncology.
According to the U.S. Centers for Disease Control and Prevention, hepatitis B is a contagious liver disease that can cause a mild illness that lasts a few weeks or a severe and serious lifelong illness. Chronic hepatitis B affects close to 350 million people and contributes to approximately 620,000 deaths annually around the world.