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Adjuvanted Hepatitis B vaccine (Recombinant) - Dynavax Technologies

Drug Profile

Adjuvanted Hepatitis B vaccine (Recombinant) - Dynavax Technologies

Alternative Names: HBsAg-1018; HBV vaccine preventative - Dynavax; HBV-ISS preventative vaccine; Hepatitis B Vaccine (Recombinant), Adjuvanted; Hepatitis B vaccine 1018-ISS conjugate - Dynavax; Hepatitis B vaccine preventative - Dynavax; HEPLISAV; HEPLISAV-B; V270

Latest Information Update: 07 May 2019

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At a glance

  • Originator Dynavax Technologies
  • Class Hepatitis B vaccines; Oligonucleotides; Synthetic vaccines
  • Mechanism of Action Immunostimulants; Toll-like receptor 9 agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Hepatitis B

Most Recent Events

  • 30 Apr 2019 Dynavax Technologies initiates enrolment in a phase I pharmacokinetics trial in USA (NCT03934736)
  • 28 Mar 2019 European Medicines Agency accepts Marketing authorization application for Hepatitis B vaccine, recombinant, adjuvanted for Hepatitis B (Prevention) for review
  • 11 Mar 2019 Dynavax Technologies Corporation resubmits the MAA to EMA for Hepatitis B (Prevention) in European Union (IM)
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