Bulevirtide: First Approval

Drugs. 2020 Oct;80(15):1601-1605. doi: 10.1007/s40265-020-01400-1.

Abstract

Bulevirtide (Hepcludex®), a first-in-class entry inhibitor, is being developed by MYR GmbH for the treatment of chronic hepatitis delta virus (HDV) and chronic hepatitis B virus (HBV) infections. Bulevirtide was recently approved in the European Union (EU) for the treatment of chronic HDV infection in HDV RNA positive adult patients with compensated liver disease. This article summarizes the milestones in the development of bulevirtide leading to this first approval for chronic HDV.

Publication types

  • Review

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Drug Approval*
  • Europe
  • Hepatitis B virus / drug effects
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / virology
  • Hepatitis D, Chronic / drug therapy*
  • Hepatitis D, Chronic / virology
  • Hepatitis Delta Virus / drug effects
  • Humans
  • Lipopeptides / administration & dosage*
  • Lipopeptides / adverse effects
  • Treatment Outcome
  • Virus Internalization / drug effects

Substances

  • Antiviral Agents
  • Lipopeptides
  • bulevirtide