Dynavax Will Not Pursue Narrow Indication For Heplisav After Meeting With FDA
This article was originally published in The Pink Sheet Daily
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.
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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.
With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.