Imlifidase

Imlifidase
Clinical data
Pronunciationim lif' i dase
Trade namesIdefirix
Other namesHMED-IdeS
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
  • EU: Rx-only [1]
Identifiers
CAS Number
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC1575H2400N422O477S6
Molar mass35071.36 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.[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]

Imlifidase was approved for medical use in the European Union in August 2020.[1][2]

Medical uses

Imlifidase is 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 programs 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]

References

  1. 1 2 3 4 5 6 7 8 9 10 "Imlifidase: EPAR". European Medicines Agency (EMA). 25 June 2020. Retrieved 24 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ↑ "New treatment to enable kidney transplant in highly sensitized patients". European Medicines Agency (Press release). 26 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.
  3. ↑ "EU/3/16/1826". European Medicines Agency (EMA). 12 January 2017. Retrieved 27 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 1 2 "EU/3/18/2096". European Medicines Agency (EMA). 13 February 2019. Retrieved 27 June 2020. Public Domain 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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