Dynavax Technologies Corporation (NASDAQ:DVAX) has released a statement regarding HEPLISAV-B, revealing that the Food and Drug Administration has requested more information about the trials involving the treatment.
HEPLISAV-B is the company’s pipeline vaccine for hepatitis B. According to the recent update from Dynavax, about the treatment reveals that the FDA has requested more information about the vaccine’s post marketing study. This comes after the meeting with the FDA advisory committee on July 28 this year. The advisory committee had 12 members voting in favor of licensing the vaccine for the treatment of hepatitis B in adults above 18 years old. Only one person voted against it and three other members of the board were absent.
The FDA committee and Dynavax also talked about the company’s proposed marketing strategy for HEPLISAV-B. The two discussed the outcome of the VRBPAC meeting and they came to an agreement that there should be more time to finalize the main details of the post-marketing trials. this conclusion was based on the feedback provided as well as its closeness to the to the scheduled Prescription Drug User Fee Act.
“Our conversation with the Agency was open and productive and confirmed our mutual understanding of the VRBPAC’s suggested requirements for the post-marketing study. We are working with our third-party providers to develop an appropriate study that addresses the advisory committee’s feedback. We now have clarity on the path forward and next steps required to complete the regulatory review of HEPLISAV-B,” stated Dynavax CEO, Eddie Gray.
Gray also noted that his company plans to respond quickly to the FDA’s request for more information about the vaccine. He also added that it is in the company’s interest towards making the vaccine available in the market to eliminate hepatitis B infection. The remaining details about the post-marketing study are expected to address various factors. These include the updated statistical analysis plan and control measures for potential biases between the study arms. It also includes a timeline for final protocol submission, time points for data review and timelines of accruing patients involved in the study.
Dynavax stock closed the latest trading session on Thursday at $17.00.