FDA Removes Clinical Hold On Dynavax’s Heplisav

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.”