FDA Issues Second CRL to Dynavax for its Hepatitis B Vaccine

Dynavax Technologies received a complete response letter (CRL) from the FDA on its Heplisav-B biologics license application (BLA).

The agency acknowledged it has not completed its review of responses received from Dynavax and is asking for more information on several issues including specific adverse effects concerning a numerical imbalance of cardiac events in a single study, new analyses of the integrated safety database across different time periods and post-marketing commitments.

The agency is not requesting additional trials and has not indicated significant concerns regarding rare serious autoimmune events.