According to the biotech, the FDA has asked for more time to hammer out the details of a post-marketing safety study. Regulators are saying they want to know more about the timelines and specifics on a trial that is intended to clarify concerns about the myocardial infarctions seen in the late-stage studies.
Investors didn’t like to see any sign of trouble after the FDA expert panel vote — especially after two earlier rejections based on safety concerns. The shares dropped 8% in after-market trading.
The details, according to the company, include more information on the:
- Timeline for the final protocol submission, study completion and final report submission
- Timeliness of accruing patients into the study
- Time points for data review
- Measures to control for potential biases between study arms
- Updated statistical analysis plan
The biotech insists, though, that it should be able to start marketing the drug with an approval by November 10, three months after the original PDUFA date.
“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,” said Eddie Gray, chief executive officer of Dynavax. “We plan to respond to the request for additional information expeditiously. We look forward to bringing this important vaccine to market to support the elimination of hepatitis B infection as a public health problem.”
In a call with analysts Thursday, Gray said the FDA had focused on the panel support they gained. “It’s an ongoing sort of process,” he noted.
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