Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ — Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company’s supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of 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 is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLISAV-B regimen for the adult hemodialysis population.