The FDA has removed the clinical hold for Dynavax Technologies’ (Dynavax) Heplisav Investigational New Drug (IND) application in individuals with chronic kidney disease.
HEPLISAV is a phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.
Reportedly, based on the FDA’s decision, Dynavax expects to initiate a phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
Dino Dina, president and CEO of Dynavax, said: “The success of our scientific approach to resolving the clinical hold on Heplisav allows us to resume development of our hepatitis B vaccine. After achieving strong efficacy data in our prior phase 3 pivotal trial, we are fully prepared to initiate the final registration trials forHeplisav.”