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February 18, 2014
09:18 EDTDVAXDynavax withdraws EU marketing application for HEPLISAV
Dynavax Technologies announced that it has withdrawn the European Marketing Authorization Application for HEPLISAV, its investigational hepatitis B vaccine. The Day 180 List of Outstanding Issues provided by the European Medicines Agency 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.
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