Guselkumab: First Global Approval

Drugs. 2017 Sep;77(13):1487-1492. doi: 10.1007/s40265-017-0800-7.

Abstract

Guselkumab (Tremfya™) is a human monoclonal IgG1λ antibody being developed by Janssen Biotech, Inc. that has been approved in the USA as a treatment for moderate-to-severe plaque psoriasis. Guselkumab inhibits the binding of interleukin 23 (IL-23) to its cell surface receptor, disrupting the type 17 helper T cell/IL-17 pathway. This article summarizes the milestones in the development of guselkumab leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacokinetics*
  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized
  • Dose-Response Relationship, Drug
  • Drug Approval
  • Drug Compounding
  • Humans
  • Immunoglobulin G / administration & dosage
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / pharmacology*
  • Immunoglobulin G / therapeutic use
  • Interleukin-23 / antagonists & inhibitors
  • Psoriasis / drug therapy*
  • United States
  • United States Food and Drug Administration

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Immunoglobulin G
  • Interleukin-23
  • guselkumab