Imlifidase

Imlifidase, brand name Idefirix, is a medication for the desensitization of highly sensitized adults needing kidney transplantation, but unlikely to receive a compatible transplant.[1]

Imlifidase
Clinical data
Pronunciationim lif' i dase
Trade namesIdefirix
Other namesHMED-IdeS
Routes of
administration		Intravenous
ATC code
Identifiers
CAS Number
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC1575H2400N422O477S6
Molar mass35071.36 g·mol−1

Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG)‑degrading enzyme of Streptococcus pyogenes.[1] 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).[1] Thus, imlifidase reduces the level of donor specific antibodies, enabling transplantation.[1]

The benefits with imlifidase are its ability to convert a positive crossmatch to a negative one in highly sensitized people to allow renal transplantation.[1] The most common side effects are infections and infusion related reactions.[1]

In June 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Imlifidase.[1][2]

Medical uses

Per the CHMP recommendation, imlifidase will be indicated for desensitization treatment of highly sensitized adult kidney transplant people with positive crossmatch against an available deceased donor.[1] The use of imlifidase should be reserved for people unlikely to be transplanted under the available kidney allocation system including prioritization programmes for highly sensitized people.[1]

History

Imlifidase was granted orphan drug designations by the European Commission in January 2017, and November 2018,[3][4] and by the U.S. Food and Drug Administration (FDA) in both February and July 2018.[5][6]

In February 2019, Hansa Medical AB changed its name to Hansa Biopharma AB.[4]

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References
  1. "Imlifidase: Pending EC decision". European Medicines Agency (EMA). 25 June 2020. Retrieved 26 June 2020. This article incorporates text from this source, which is in the public domain.
  2. "New treatment to enable kidney transplant in highly sensitised patients". European Medicines Agency (Press release). 26 June 2020. Retrieved 26 June 2020. This article incorporates text from this source, which is in the public domain.
  3. "EU/3/16/1826". European Medicines Agency (EMA). 12 January 2017. Retrieved 27 June 2020. This article incorporates text from this source, which is in the public domain.
  4. "EU/3/18/2096". European Medicines Agency (EMA). 13 February 2019. Retrieved 27 June 2020. This article incorporates text from this source, which is in the public domain.
  5. "Imlifidase Orphan Drug Designation and Approval". U.S. Food and Drug Administration (FDA). 3 July 2018. Retrieved 27 June 2020.
  6. "Imlifidase Orphan Drug Designation and Approval". U.S. Food and Drug Administration (FDA). 14 February 2018. Retrieved 27 June 2020.

Further reading
  • "Imlifidase". Drug Information Portal. U.S. National Library of Medicine.


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