FDA Pushes Back Dynavax’s HEPLISAV-B PDUFA Date

The FDA has extended the PDUFA date of Dynavax’s investigational hepatitis B vaccine Heplisav-B by three months to review new data in the company’s resubmitted BLA.

Dynavax submitted new individual data sets to the FDA on April 8 in response to an agency request for additional data, leading the agency to push back the PDUFA deadline to Dec. 15 to ensure it has time to review the new materials.

The FDA rejected Dynavax’s original submission for the hepatitis B vaccine in February 2013, citing a lack of robust safety data. To compensate, Dynavax has conducted a safety trial to provide supplementary data.