Dynavax Withdraws European Marketing Application for Heplisav

Dynavax is withdrawing its European marketing application for its Heplisav hepatitis B vaccine after the European Medicines Agency voiced concerns with the drugmaker’s safety database. The agency said it is too small to preclude a risk of less common serious adverse events.

The Berkeley, Calif.-based drugmaker said it plans to initiate a new trial, HBV-23, in order to collect more clinical safety data in the first quarter of this year, said spokesman Michael Ostrach.

The FDA expressed similar concerns a year ago in a complete response letter that said Dynavax’s safety data on Heplisav were not strong enough to approve the vaccine for adults ages 18 to 40. Dynavax is in discussions with the FDA concerning the letter and is considering resubmitting the vaccine for chronic kidney disease and/or in adults ages 40 and over, Ostrach told Drug Daily Bulletin.

Heplisav is Dynavax’s lead investigational Phase III product candidate. — Lena Freund

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