FDA Delays Ruling on Heplisav-B

The investigational hepatitis-B drug has been rejected for approval twice in the past 3 years, but creator Dynavax Technologies still hopes for an early 2018 US commercial release.

Days after receiving support from US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) on its safety data, Dynavax Technologies announced a 3-month delay for the FDA's decision on the biologics license application (BLA) of Heplisav-B.

The investigational hepatitis B recombinant drug, a potential adult vaccine for the virus, was less than a week from away from receiving FDA BLA ruling.

The reason given for the delay comes from the very same late-July VRBPAC session that resulted in a 12-1 (with 3 abstentions) vote to back Dynavax's safety studies regarding Heplisav-B. The FDA requested further detailed infomation about the drug's post-marketing study, based on feedback from its voting committee.

Eddie Gray, chief executive officer of Dynavax, said conversations with FDA were open and productive, confirming a "mutual understanding of the VRBPAC's suggested requirements for the post-marketing study."

"We are working with our third-party providers to develop an appropriate study that addresses the advisory committee's feedback," Gray said. "We now have clarity on the path forward and next steps required to complete the regulatory review of HEPLISAV-B."

Dynavax intends to include post-marketing study details such as a timeline for the final protocol submission, study completion and final report submission, timeliness of accruing patients into the study, time points for data review, measures to control for potential biases between study arms, and updated statistical analysis plan.

The FDA and Dynavax will have up to 3 months to agree on the post-marketing study prior to an updated Prescription Drug User Fee Act date, previously intended for August 10. Despite the setback, Dynavax express intent to still commercially launch Heplisav-B in the US in early 2018.

The roadblock is just one of many the drug has faced in its pursuit of the market. Though it has reported favorable marks for its lighter use — 2 doses every month — it was twice previously denied its marketing application by the FDA in the past 3 years.

A press release regarding the news was made available.

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