Heplisav regulatory update

FDA's Vaccines and Related Biological Products Advisory Committee voted 8-5 with 1 abstention that Dynavax had not gathered enough safety data to support approval of Heplisav, an adjuvanted vaccine for HBV. The panel did vote 13-1 that the company demonstrated Heplisav's efficacy.

Heplisav is a hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences that target toll-like receptor 9 (TLR9). In briefing documents and at the meeting, FDA presented data from 4,425 patients treated with Heplisav that showed no difference in adverse events, serious adverse events or autoimmune-related events between the Heplisav group and active comparator Engerix-B from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.). However, because there are no approved TLR9-based adjuvants, the majority of panel members requested additional safety data preapproval to fully characterize the Heplisav's potential risks. Edgar Marcuse, permanent voting member and associate medical director at Seattle Children's Hospital, suggested that data for about 8,000 to 10,000 patients could be sufficient. ...