Chemistry:Imlifidase
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| Pronunciation | im lif' i dase |
| Trade names | Idefirix |
| Other names | HMED-IdeS |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
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| Identifiers | |
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| Chemical and physical data | |
| Formula | C1575H2400N422O477S6 |
| Molar mass | 35071.36 g·mol−1 |
Imlifidase, brand name Idefirix, is a medication for the desensitization of highly sensitized adults needing kidney transplantation, but unlikely to receive a compatible transplant.[3]
Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG)‑degrading enzyme of Streptococcus pyogenes.[3] It cleaves the heavy chains of all human IgG subclasses (but no other immunoglobulins), eliminating Fc-dependent effector functions, including CDC and antibody-dependent cell-mediated cytotoxicity (ADCC).[3] Thus, imlifidase reduces the level of donor specific antibodies, enabling transplantation.[3]
The benefits with imlifidase are its ability to convert a positive crossmatch to a negative one in highly sensitized people to allow renal transplantation.[3] The most common side effects are infections and infusion related reactions.[3]
Imlifidase was approved for medical use in the European Union in August 2020.[3][5]
Medical uses
Imlifidase is indicated for desensitization treatment of highly sensitized adult kidney transplant people with positive crossmatch against an available deceased donor.[3] The use of imlifidase should be reserved for people unlikely to be transplanted under the available kidney allocation system including prioritization programs for highly sensitized people.[3]
History
Imlifidase was granted orphan drug designations by the European Commission in January 2017, and November 2018,[6][7] and by the U.S. Food and Drug Administration (FDA) in both February and July 2018.[8][9]
In February 2019, Hansa Medical AB changed its name to Hansa Biopharma AB.[7]
References
- ↑ 1.0 1.1 "Idefirix". 19 July 2023. https://www.tga.gov.au/resources/auspmd/idefirix.
- ↑ "Idefirix (Hansa Biopharma (Australia) Pty Ltd)". 28 July 2023. https://www.tga.gov.au/resources/prescription-medicines-registrations/idefirix-hansa-biopharma-australia-pty-ltd.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 "Imlifidase: EPAR". 25 June 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/idefirix. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Idefirix Product information". https://ec.europa.eu/health/documents/community-register/html/h1471.htm.
- ↑ "New treatment to enable kidney transplant in highly sensitized patients". European Medicines Agency (Press release). 26 June 2020. Archived from the original on 29 June 2020. Retrieved 26 June 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "EU/3/16/1826". 12 January 2017. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3161826.
This article incorporates text from this source, which is in the public domain.
- ↑ 7.0 7.1 "EU/3/18/2096". 13 February 2019. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3182096. This article incorporates text from this source, which is in the public domain.
- ↑ "Imlifidase Orphan Drug Designation and Approval". 3 July 2018. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=643118.
- ↑ "Imlifidase Orphan Drug Designation and Approval". 14 February 2018. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=623817.
Further reading
- "Imlifidase Inhibits HLA Antibody-Mediated NK Cell Activation and Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) In Vitro". Transplantation 104 (8): 1574–1579. October 2019. doi:10.1097/TP.0000000000003023. PMID 31644495.
- "Desensitization using imlifidase and EndoS enables chimerism induction in allosensitized recipient mice". Am. J. Transplant. 20 (9): 2356–2365. March 2020. doi:10.1111/ajt.15851. PMID 32185855.
- "IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody". Ann. Surg. 268 (3): 488–496. September 2018. doi:10.1097/SLA.0000000000002924. PMID 30004918. https://dx.doi.org/10.1097%2FSLA.0000000000002924.
- "Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients". Am. J. Transplant. 18 (11): 2752–2762. November 2018. doi:10.1111/ajt.14733. PMID 29561066.
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