Heplisav-B regulatory update

FDA canceled a Nov. 16 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss a BLA for HBV vaccine Heplisav-B. The PDUFA date is Dec. 15. The agency said the meeting was canceled “to allow time for FDA to review and resolve several outstanding issues.” FDA did not provide a new date for the meeting but said it “intends to continue evaluating and will schedule an Advisory Committee meeting in the future, as needed.” Dynavax said remaining questions “will be addressed between Dynavax and the review team via the normal process.” The company said it is prepared to respond to any information requests from FDA in the upcoming weeks.

Dynavax said FDA will not review data from the diabetic subpopulation of the company’s Phase III HBV-23 trial comparing Heplisav-B vs. Engerix-B. In January, Dynavax said Heplisav-B met HBV-23’s co-primary endpoints, including showing non-inferiority to Engerix-B in seroprotection in both diabetic subjects and among all study subjects. The company conducted the trial to create a sufficiently sized safety database for FDA, which issued a complete response letter for the candidate in 2013 (see BioCentury, Jan. 11). ...