Dynavax has met with the European Medicines Evaluation Agency (EMEA) to discuss its plans for continued clinical development of HEPLISAV phase 3 investigational adult hepatitis B vaccine in Europe.
In a Scientific Advice letter, EMEA expressed a general agreement with Dynavax’s proposed plan to develop HEPLISAV for adult populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups.
In addition to that EMEA suggested that Dynavax consider the development of HEPLISAV for adults under 40 years of age who need rapid protection.
Dino Dina, president and CEO of Dynavax, said: “As we advance our development plans for HEPLISAV, EMEA’s scientific advice supports expansion of our targeted population in Europe to include subjects who need rapid protection against hepatitis B infection. A vaccine that demonstrates potential to provide faster and better protection than current vaccines could transform vaccination regimens and outcomes, particularly for individuals with increased risk of infection.”