FDA Panel Votes to Recommend Dynavax's Hepatitis B Vaccine; Hepsilav Can Compete With GlaxoSmithKline's Engerix-B

Published: Jul 31, 2017

FDA Panel Votes to Recommend Dynavax's Hepatitis B Vaccine; Hepsilav Can Compete With GlaxoSmithKline's Engerix-B July 31, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Berkeley, Calif. – A U.S. Food and Drug Administration (FDA) advisory committee gave a thumb’s-up recommendation for Dynavax Technologies Corporation ’s Heplisav-B hepatitis B vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 to recommend Heplisav-B in adults 18 years or older. Three members of the committee abstained. The committee also commented on the design of Dynavax’s proposed post-marketing pharmacovigilance plan for the vaccine. The panel did not vote on the immunogenicity of the vaccine. An earlier VRPBAC panel voted 13 to 1 that the Phase III clinical trial data supported the immunogenicity of the vaccine.

“We are encouraged by the committee’s positive vote for Hepslisav-B, which we believe will become an important new tool in the fight against hepatitis B infection if approved by the FDA,” said Eddie Gray, Dynavax’s chief executive officer, in a statement. “Clinical studies of Heplisav-B have shown that the vaccine provides increased rates of seroprotection. In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.”

John Carroll, writing for Endpoints News, says, “Efficacy was never really in doubt. The data are solid. But there was plenty of fretting about Heplisav’s safety profile, after regulators spotlighted an imbalance of deaths and cardiac events which has never been explained. The internal FDA review last Wednesday forced the stock down 10 percent but it rocketed up 80 percent Friday evening after the experts weighed in on ways that the biotech could keep a careful eye on the health of the people taking their vaccine.”

The FDA is not required to follow the recommendation of its advisory panels, but it usually does. And Carroll notes that the current presidential administration and the FDA is pushing for approvals over delays.

Matt Eckler, an analyst with RBC, thinks the FDA will likely approve by August 10 and Dynavx will launch next year, whether it can partner with someone or not.

Eckler wrote in a note to investors, “Prior to the positive vote, panel members expressed lingering concerns over the MI (myocardial infarction) signal seen in HBV-23, as well as the sufficiency of the proposed design of the post marketing surveillance program. The current proposal from Dynavax is to conduct observational electronic medical record review at Kaiser Permanente Northern California to compare 3-point MACE, and pre-specified immune-mediate events, in 20,000 Heplisav-B recipients vs 20,000 persons who receive another hepatitis B vaccine.”

Panel members were not completely on board with this. Concerns involved the possibility for selection against high-risk patients, a limited ability to detect a safety signal, and whether the time frame allowed for determination of a definitive conclusion. Eckler also said, “Additionally, panel members expressed the view that full safety data should be in Heplisav’s label, but that such a label may cause physicians to select against using in high-risk patients for whom the unmet medical need is greatest.”

Hepsilav, if approved, will have to compete with GlaxoSmithKline ’s Engerix-B.

Dynavax is currently trading at $15.98, up from $9.90 on July 25.

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