Dynavax drops request for EU approval of Hepatitis B vaccine

Dynavax (DVAX +1.7%) withdraws its application for the European approval of the company's Hepatitis B vaccine Heplisav after the European Medicines Agency (EMA) indicated that the product's safety database is too small to rule out the risk of less common serious side-effects.

Dynavax plans to soon start another Heplisav trial in order to provide a large enough database. (PR)

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Comments (3)
    , contributor
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    Not a surprising development as I never thought DVAX stands a chance presently for approval in Europe, because it faces the same, if not even stronger, huddle due to GSK's dominant position. Don't forget in the last ADCOM vote, the chairman of the committee cast the ONLY no vote for its efficacy while its efficacy is so superior to GSK's vaccine. Of course this Chair happened to be a consultant to GSK! Being an European co, GSK will have even bigger influence there. Might as well get the vaccine approved here in the US and work on Europe later.
    18 Feb 2014, 11:39 AM Reply Like
  • appledad
    , contributor
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    Ridiculous that they did not plan their studies to have the statistical power required to demonstrate safety at the beginning of phase III.
    18 Feb 2014, 03:52 PM Reply Like
  • Dave Dawson
    , contributor
    Comments (4) | Send Message
    Agree that a statistical plan should have been cleared with FDA before the phase III was launched. I have seen the FDA hold companies accountable for planning that the FDA failed to give advice about during trial planning meetings. I am surprised that the adjuvant did not have its own safety testing independant of the antigen prior to the phase III. Current mgmt seems to be on the right track
    19 Feb 2014, 02:37 PM Reply Like
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