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Dynavax withdraws Heplisav MAA

February 19, 2014 1:41 AM UTC

Dynavax Technologies Corp. (NASDAQ:DVAX) withdrew an MAA from EMA for Heplisav, its adjuvanted HBV vaccine. According to the company, EMA said Heplisav's current safety database is too small to rule out a risk of less common serious adverse events. Dynavax withdrew the MAA because it had insufficient time to collect the necessary clinical data. Last year, FDA also asked for additional safety data for Heplisav during a meeting to discuss a complete response letter for a BLA for the vaccine, which is comprised of hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences that target toll-like receptor 9 (TLR9). Dynavax said it plans to "shortly" start the Phase III HBV-23 trial to create a sufficient safety database for Heplisav for both agencies (see BioCentury Extra, June 10, 2013). ...