FDA Advisory Panel Votes in Favor of Investigational Hepatitis B Vaccine

Heplisav-B aims to boost a patient’s own immune response to fight off HBV.

An FDA advisory committee backed the safety of an experimental vaccine for the hepatitis B virus (HBV), according to Reuters.

The vaccine, Heplisav-B, was previously rejected twice by the regulatory agency due to concerns regarding the safety of the vaccine, according to Reuters.

Most of the panel discussion focused on the need for Dynavax Technologies Corp to carefully track patient outcomes, Reuters reported.

The committee voted 12 to 1 in favor of the data supporting the safety of Heplisav-B for adults 18 years and older. A prior panel voted 13 to 1 that clinical trial data support the efficacy of the vaccine, according to Dynavax.

In an earlier review, FDA staffers said that although Heplisav-B is effective, there were more deaths and serious heart issues in patients who received the vaccine than those who took a rival product, according to Reuters.

The vaccine was rejected for the second time in November, with the FDA citing unresolved safety concerns. As a result, Dynavax’s shares dropped by approximately 70% to $3.20, according to Reuters.

By mid-day Monday, however, company shares shot up more than 70% following the committee’s favorable vote.

“[The] panel vote is a major win for Dynavax,” Anupam Rama, a JP Morgan analyst told CNBC. “We now believe that Heplisav has a high probability of approval by the August 10th [FDA review deadline.”

Heplisav-B is designed to enhance the body’s own immune response to HBV. An estimated 257 million individuals are living with the virus worldwide.

Peak sales of the vaccine could reach $650 million per year if approved, William Blair analyst Katherine Xu told Reuters.

Furthermore, because Heplisav-B has an easier dosing schedule than GlaxoSmithKline’s Engerix-B, it could become the new standard of care.

The FDA is expected to come to a decision next month, according to Reuters.