Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says
FDA calls off November meeting to give 'more time to review and resolve several outstanding issues' with adjuvanted hepatitis B vaccine; Dynavax says agency determined meeting was not necessary to ensure regulatory decision by Dec. 15 goal date.
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Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.
US agency's decision not to hold a February advisory committee review of tardive dyskinesia treatment viewed positively by Neurocrine, which emphasized quality of its communications with the review division and the drug's breakthrough therapy status.
The past year has seen a sharp increase in the number of complete response letters issued to novel agent applications, and some sponsors are growing more publicly critical of the agency's timing of requests for more information; Dynavax’s complaint regarding the handling of Heplisav-B is the latest example.