FDA Lifts Clinical Hold On Dynavax's Hep B Vaccine Heplisav, Narrows Population
This article was originally published in The Pink Sheet Daily
The firm is hoping to gain licensure for chronic kidney disease patients first, and eventually to expand the indication to the broader hepatitis B vaccination population.
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After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.
Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.
The company will be collecting additional safety data for approval of its hepatitis B vaccine in adults 18 to 70 years old; the size, duration and cost of the study are yet to be determined.