ARTICLE | Clinical News

FDA panel backs Heplisav-B, requests details for postmarketing study

August 4, 2017 7:54 PM UTC

FDA's Vaccines and Related Biological Products Advisory Committee voted 12 to 1, with 3 abstentions, that available safety data support the use of HBV vaccine Heplisav-B from Dynavax Technologies Corp. (NASDAQ:DVAX) in adults. The committee also stressed the importance of a well-designed postmarketing study to assess observed imbalances in cardiovascular events.

The reviewers were concerned with imbalances in the incidence of myocardial infarction (MI) in the Phase III HBV-23 trial, in which 19 patients treated with Heplisav-B had an MI vs. 3 patients treated in the trial's Engerix-B comparator arm. However, several panel members said safety should be considered on a risk/benefit scale, emphasizing Heplisav-B’s superior efficacy over current options and the high public health need. One member suggested that the FDA label include a warning or alert for patients with increased CV risk factors...