BERKELEY, CA, Feb 18, 2014 (Marketwired via COMTEX) --
Dynavax Technologies Corporation
DVAX
+1.14%
announced today that
it has withdrawn the European Marketing Authorization Application
(MAA) for HEPLISAV, its investigational hepatitis B vaccine. The Day
180 List of Outstanding Issues provided by the European Medicines
Agency (EMA) indicated that the current HEPLISAV safety database is
considered to be too small to rule out a risk of less common serious
adverse events. Dynavax has chosen to withdraw the application
because the required timeframe for response under the MAA procedure
is not long enough to permit the collection of the necessary clinical
data. Dynavax expects to begin shortly an additional HEPLISAV
clinical trial, HBV-23, that is intended to provide a safety database
sufficient to support licensure.
Read complete release here: Labels: EMA, HEPLISAV