FDAnews Drug Daily Bulletin

FDA Vaccine Panel Says Dynavax’s Hepislav-B Meets Safety Requirements

Aug. 3, 2017

An FDA vaccine advisory panel voted 12-to-1 last Friday to recommend approval of Dynavax’s Hepislav-B in adults for the prevention of hepatitis B.

The agency’s Vaccines and Related Biological Products Advisory Committee said the additional data submitted by the company supported conclusions of safety, fulfilling a previous FDA request. Three committee members abstained from voting.

Dynavax first submitted its BLA for the recombinant vaccine in April 2012, with two Phase III trials comparing Hepislav with GlaxoSmithKline’s Engerix-B. An advisory committee met in November to review the BLA because Hepislav employs a novel immune system-stimulating ingredient.

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