FDA Committee Supports Safety Data of Hepatitis B Vaccine
HEPLISAV-B reported favorable marks for its lighter use — two doses every month — but was twice previously denied its marketing application in the past 3 years.
The US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted favorably to support the presented safety data of potential hepatitis B treatment HEPLISAV-B.
In a 12-1 vote — with 3 committee member abstentions — last week, the VRBPAC favored that the investigational treatment's safety data supported licensure for hepatitis B infection immunization in adults 18 years of age or older.
The vote proceeds a 13-1 decision to support the potential vaccine's immunogenicity, based on data from Phase III clinical trials. Though the committee's vote of approval does not play an immediate role in Dynavax Technologies' application for new drug licensing, it could serve as dependable advisory for the FDA.
Eddie Gray, Dynavax chief executive officer, said he believes the vaccine would become an "important new tool in the fight against hepatitis B," pending FDA approval.
"Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection," Gray said. "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."
There are currently 2 FDA-approved hepatitis B vaccinations on the market. HEPLISAV-B reported favorable marks for its lighter use — two doses every month — but was twice previously denied its marketing application in the past 3 years.
If the vaccine receives FDA approval, Dynavax intends to commercially launch HEPLISAV-B in the US in early 2018.
A press release regarding the vote was made available.
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