Imlifidase: First Approval

Drugs. 2020 Nov;80(17):1859-1864. doi: 10.1007/s40265-020-01418-5.

Abstract

Imlifidase (IdefirixTM), a cysteine protease derived from the immunoglobulin G (IgG)‑degrading enzyme of Streptococcus (S.) pyogenes is being developed by Hansa Biopharma AB for treatment of transplant rejection and rare IgG-mediated autoimmune conditions. In August 2020, intravenous imlifidase received its first global approval in the EU for desensitization treatment of highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor. Imlifidase is currently undergoing clinical evaluation for the prevention of kidney transplant rejection in the USA, Australia, France and Austria, and clinical development is underway for anti-glomerular basement membrane disease, and for Guillain-Barre syndrome in France, the UK and the Netherlands. This article summarizes the milestones in the development of imlifidase leading to this first approval for desensitization treatment of highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor.

Publication types

  • Review

MeSH terms

  • Administration, Intravenous
  • Animals
  • Anti-Glomerular Basement Membrane Disease / drug therapy*
  • Anti-Glomerular Basement Membrane Disease / immunology
  • Bacterial Proteins / pharmacology
  • Bacterial Proteins / therapeutic use*
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Desensitization, Immunologic / methods
  • Disease Models, Animal
  • Drug Approval*
  • Drug Evaluation, Preclinical
  • European Union
  • Graft Rejection / drug therapy*
  • Guillain-Barre Syndrome / drug therapy*
  • Guillain-Barre Syndrome / immunology
  • HLA Antigens / immunology
  • Humans
  • Immunoglobulin G / immunology
  • Immunoglobulin G / metabolism
  • Kidney Failure, Chronic / surgery
  • Kidney Transplantation / adverse effects
  • Randomized Controlled Trials as Topic
  • Rare Diseases / drug therapy
  • Rare Diseases / immunology

Substances

  • Bacterial Proteins
  • HLA Antigens
  • Immunoglobulin G
  • Mac-1-like protein, Streptococcus