DVAX - FDA Declines To Approve Expanded Use of Dynavax's Hepatitis B Vaccine In Hemodialysis Patients | Benzinga
Tuesday, Dynavax Technologies Corporation (NASDAQ:DVAX) provided a regulatory update for its supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis.
The FDA has issued a Complete Response Letter stating that the application did not provide sufficient data to fully evaluate the effectiveness or safety of a four-dose regimen of HEPLISAV-B.
The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and ...