Yesterday, the 18th of February 2014, Dynavax announced that it would be withdrawing it’s European Marketing Authorisation Application for it’s investigational hepatitis B vaccine Heplisav.
The decision comes after the the European Medicines Agency indicated that the current safety data is too small to rule out the risk of less common but serious adverse events. Dynavax state that the time frame they were left with in which to collect further data did not allow them enough time.
This is despite an $55 million 8,000 person trial set to ‘begin shortly’. This trial was planned in the wake of the American Food and Drug Administration raising similar concerns regarding the patient sample size.
Perhaps Dynavax’s withdraw from the European market place is not surprising given the dominance of europe based GSK‘s Engerix-B. Even though phase II/III trials suggested that Heplisav was more effective than Engerix-B in achieving their primary clinical enpoints, GSK undoubtedly has a strong hold on the European markets and this could well have played a factor in Dynavax’s decision to abandon Europe for the moment.
See the press release here.