Heplisav: Phase III started

Dynavax began the double-blind, U.S. Phase III HBV-23 trial to compare Heplisav vs. Engerix-B in 8,250 patients ages 18-70 years. Subjects will receive 2 doses of Heplisav at 0 and 1 month or 3 Engerix-B doses at 0, 1 and 6 months. Dynavax said the trial was designed to address a February 2013 complete response letter for Heplisav and is intended to provide a sufficiently-sized safety database for FDA to complete its review of a BLA for Heplisav (see BioCentury, March 4, 2013; June 17, 2013 & Oct. 28, 2013). HBV-23 will evaluate all subjects for safety for 1 year. ...