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Imlifidase: First Approval

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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.

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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.

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Zaina T. Al-Salama

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  1. Zaina T. Al-Salama
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Correspondence to Zaina T. Al-Salama.

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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.

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Additional information

Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12981116.

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Al-Salama, Z.T. Imlifidase: First Approval. Drugs 80, 1859–1864 (2020). https://doi.org/10.1007/s40265-020-01418-5

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