FDA Agrees with Dynavax on Consistency of HEPLISAV Lots

Dynavax Technologies Corporation DVAX today announced that the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."