WEDNESDAY, SEPTEMBER 28, 2016

Dynavax Technologies has conference call with FDA on HEPLISAV vaccine

Dynavax Technologies Corporation reported on Monday it recently had a conference call with the U.S. Food and Drug Administration regarding its Biologic License Application for HEPLISAV, an investigational hepatitis B vaccine for adults.

The meeting with the FDA took into account recommendations made in November by the Vaccines and Related Biological Products Advisory Committee about Dynavax's safety database. The FDA told Dynavax that its safety databases requires additional subjects, VRBPAC has strongly endorsed HEPLISAV's immunogenicity, a risk/benefit analysis of HEPLISAV's use in a small population found that such a study did not address a safety database shortfall while also unnecessarily restricting the population that could benefit from HEPLISAV's approval and additional safety data would aid future reviews.

"We are encouraged by the supportive feedback received from the FDA and appreciate the informative interactions and clarity provided regarding HEPLISAV's path toward approval in the broader indication," Eddie Gray, Dynavax's chief executive officer, said. "We understand the rationale for the Agency's recommendations and will give full consideration to their feasibility and timing as we advance HEPLISAV's development."

Dynavax will be meeting with the FDA soon to discuss additional safety data and questions asked by the FDA in the Complete Response Letter on the manufacturing and testing of HEPLISAV.