Imlifidase: First Approval
Acknowledgements During the peer review process, the manufacturer of imlifidase was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Declarations
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest Zaina T. Al-Salama is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.
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Abstract
Imlifdase (IdefrixTM), 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 imlifdase 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.
Imlifdase 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 imlifdase leading to this first approval for desensitization treatment of highly sensitized adult kidney transplant patients
with positive crossmatch against an available deceased donor.
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