Imlifidase
Pharmaceutical drug
From Wikipedia, the free encyclopedia
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]
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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 | |
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| Identifiers | |
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| Chemical and physical data | |
| Formula | C1575H2400N422O477S6 |
| Molar mass | 35071.36 g·mol−1 |
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]
