FDA delays decision on Dynavax's hepatitis B vaccine Heplisav-B; shares fall

Shares in Dynavax fell as much as 11 percent Thursday after the FDA delayed a final decision regarding the approval of the company's hepatitis B vaccine Heplisav-B by up to three months. The drugmaker disclosed that the agency has requested additional information regarding its post-marketing study for Heplisav-B. The decision comes after an FDA advisory panel last month voted in favour of approval of the vaccine for use in adults. (For related analysis, read ViewPoints: Third time's a charm for DynaVax's HBV vaccine.)

"We are working with our third-party providers to develop an appropriate study that addresses the advisory committee's feedback," remarked Dynavax CEO Eddie Gray, adding "we now have clarity on the path forward and next steps required to complete the regulatory review of Heplisav-B." 

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Specifically, the FDA requested clarity concerning the timing of the final protocol submission, completion of the study and final report submission, as well as the timelines of accruing patients. Further, the FDA asked for additional details regarding the time points for reviewing data, steps taken to control biases between the study arms and a revised statistical analysis plan. 

The regulator now expects to complete its review of Heplisav-B by November 10. Dynavax noted that the decision does not affect its plans to launch the vaccine early next year in the US. 

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