FDAnews
www.fdanews.com/articles/174867-dynavaxs-hep-b-vaccine-meets-primary-endpoints

Dynavax’s Hep B Vaccine Meets Primary Endpoints

January 13, 2016

Dynavax by March will refile a BLA for its hepatitis B vaccine Heplisav-B by the end of this quarter after seeing success in a Phase 3 trial.

The investigational drug demonstrated efficacy in a head-to-head trial versus GlaxoSmithKline’s Engerix-B vaccine in adults 18 to 70. Heplisav-B offered greater seroprotection against the virus across the board, particularly in diabetic patients considered to be at greater risk.

Dynavax originally submitted its Heplisav-B BLA in 2012, and it received a February 2013 FDA complete response letter. The agency wanted more safety data, given autoimmune risks with novel adjuvants, and it asked for additional process validation data on manufacturing controls.