Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include a four dose Heplisav-B vaccine [hepatitis B vaccine (recombinant), adjuvanted] regimen for adults on haemodialysis.
The US FDA has issued a complete response letter in response to the supplemental biologics license application, stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of Hepliosav-B.
