Heplisav B review date at FDA for Hepatitis B is extended to 15 December 2016

Dynavax Technologies said that the FDA will now need until mid-December to assess whether to approve Heplisav B vaccine after the company submitted a new data aimed at meet FDA concerns. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) action date for Heplisav-B has now been extended by three months to 15 December 2016.

Comment: In early 2016, Dynavax released its third Phase III study for Heplisav B, comparing it with Engerix-B from GSK in order to provide a sufficiently-sized safety database for the FDA to complete its review of Dynavax�s BLA. The new trial met both of its co-primary endpoints with the rates of clinically significant adverse events consistent with randomization. The vaccine also provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.

Comment: Dynavax hopes to differentiate Heplisav B from other treatments as it is injected in two doses over one-month compared to its rivals which are administered in three doses over a six-month period.