Heplisav Seems Headed For Approval, But With More Robust Postmarketing Study

30 Jul 2017

• By Michael Cipriano

Safety of Dynavax's hepatitis B vaccine gets thumbs up from US FDA advisory committee, but panel remained concern that postmarketing proposal doesn't address questions about potential link to cardiovascular events.

Dynavax Technologies Corp. looks poised to finally get its hepatitis B vaccine Heplisav (rHBsAg-1018 ISS) to market, but it could require a more robust postmarketing plan than it has initially proposed to the US FDA.

During its July 28 review, the agency's Vaccines and Related Biological Products Committee voted 12 to 1 – with three...