Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population
This article was originally published in Pharmaceutical Approvals Monthly
In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.
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The company will be collecting additional safety data for approval of its hepatitis B vaccine in adults 18 to 70 years old; the size, duration and cost of the study are yet to be determined.
FDA’s Vaccines and Related Biological Products Advisory Committee recommended 8 to 5 with one abstention that Dynavax acquire more safety data pre-licensure for its hepatitis B vaccine.
The sponsor’s proposal for a post-approval cohort safety study in 30,000 patients failed to alleviate the concerns of a majority of the vaccines advisory committee, which voted 8 to 5 with one abstention that available data do not support the safety of the hepatitis B vaccine.