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Dynavax withdraws European marketing application for hepatitis B vaccine
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Dynavax Technologies Corp. has announced it will withdraw its European Marketing Authorization Application for its investigational hepatitis B vaccine.
A company statement said the European Medicines Agency (EMA) determined that the current safety database for Heplisav is “too small to rule out a risk of less common serious adverse events,” and the required response time is too limited to gather the required clinical data.
The company statement said it expects to soon begin an additional Heplisav clinical trial to support EMA licensure.
In February 2013, the FDA also requested additional safety data regarding Heplisav.
The drug is a recombinant vaccine consisting of hepatitis B surface antigen and a toll-like receptor 9 agonist developed to increase immune response.