Dynavax Technologies ($DVAX) has a new FDA Adcomm date for consideration of its hepatitis B vaccine, Heplisav-B, after the agency earlier this year pushed back its PDUFA to December 15 over safety concerns.
The Berkeley, CA-based company said on Friday that the Vaccines and Related Biological Products Advisory Committee will review its BLA for Heplisav-B on Nov. 16. Dynavax CEO Eddie Gray said in a statement that the company is continuing to work closely with the FDA through the review process as it moves toward its goal of FDA approval.
That approval became a little less certain in April after the FDA asked for individual trial data sets that had been provided as integrated data and then determined that the addition of these large data sets represented a “major amendment” to its new BLA and so required a “full review.”
The waiting game is not new for Dynavax, which in 2012 had its original application turned down by an FDA panel over concerns about the size of the safety database and the potential to detect rare autoimmune events. At the beginning of this year, the company said it released its third Phase III study for the vax, comparing it with GlaxoSmithKline’s ($GSK) Engerix-B in order to provide a “sufficiently-sized safety database for the FDA” to complete its review of Dynavax’s BLA.
In a note to investors this week, RBC Capital Markets analyst Simos Simeonidis pointed out that based on that study and two prior Phase III trials, “Heplisav-B is clearly efficacious.” But he said that the FDA’s decision to have a second Adcomm review suggests “lingering concerns about Heplisav-B’s safety profile.”
Simeonidis said some investors will see it “as increasing the risk to its approval, regardless of the outcome of the panel and the eventual fate of the BLA.”
In addition to GSK, Merck ($MRK) already sells a hepatitis B vaccine, while Gilead ($GILD), Bristol-Myers Squibb ($BMY) and Biogen ($BIIB), among other companies, are developing new drugs to treat the disease. Dynavax sees its competitive edge coming from dosing. Its vax is injected in two doses over one month, instead of three doses over a six-month schedule for rivals.
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