DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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MDSFSANQEI RYSEVTPYHV TSVWTKGVTP PANFTQGEDV FHAPYVANQG WYDITKTFNG
KDDLLCGAAT AGNMLHWWFD QNKDQIKRYL EEHPEKQKIN FNGEQMFDVK EAIDTKNHQL
DSKLFEYFKE KAFPYLSTKH LGVFPDHVID MFINGYRLSL TNHGPTPVKE GSKDPRGGIF
DAVFTRGDQS KLLTSRHDFK EKNLKEISDL IKKELTEGKA LGLSHTYANV RINHVINLWG
ADFDSNGNLK AIYVTDSDSN ASIGMKKYFV GVNSAGKVAI SAKEIKEDNI GAQVLGLFTL
STGQDSWNQT N
Imlifidase
イムリフィダーゼ;
| Formula |
C1575H2400N422O477S6
|
|---|---|
| CAS |
1947415-68-0
|
| Mol weight |
35070.8397
|
EMA APPROVED, 2020/8/25, Idefirix
Pre-transplant treatment to make patients with donor specific IgG eligible for kidney transplantation
Immunosuppressant, Immunoglobulin modulator (enzyme)
Imlifidase is under investigation in clinical trial NCT02854059 (IdeS in Asymptomatic Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients).
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]
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]
| PHASE | STATUS | PURPOSE | CONDITIONS | COUNT |
|---|---|---|---|---|
| 2 | Recruiting | Treatment | Anti-Glomerular Basement Membrane Disease | 1 |
| 2 | Recruiting | Treatment | Guillain-Barré Syndrome (GBS) | 1 |
| 2 | Recruiting | Treatment | Kidney Transplant Rejection | 1 |
| 2 | Terminated | Treatment | Thrombotic Thrombocytopenic Purpura (TTP) | 1 |
| Not Available | Recruiting | Not Available | Kidney Transplant Failure and Rejection | 1 |
References
- ^ Jump up to:a b c d e f g h i “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. - ^ “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.
- ^ “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.
- ^ Jump up to:a b “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.
- ^ “Imlifidase Orphan Drug Designation and Approval”. U.S. Food and Drug Administration (FDA). 3 July 2018. Retrieved 27 June 2020.
- ^ “Imlifidase Orphan Drug Designation and Approval”. U.S. Food and Drug Administration (FDA). 14 February 2018. Retrieved 27 June 2020.
Further reading
- Ge S, Chu M, Choi J, Louie S, Vo A, Jordan SC, et al. (October 2019). “Imlifidase Inhibits HLA Antibody-Mediated NK Cell Activation and Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) In Vitro”. Transplantation. doi:10.1097/TP.0000000000003023. PMID 31644495.
- Lin J, Boon L, Bockermann R, Robertson AK, Kjellman C, Anderson CC (March 2020). “Desensitization using imlifidase and EndoS enables chimerism induction in allosensitized recipient mice”. Am. J. Transplant. doi:10.1111/ajt.15851. PMID 32185855.
- Lonze BE, Tatapudi VS, Weldon EP, Min ES, Ali NM, Deterville CL, et al. (September 2018). “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. doi:10.1097/SLA.0000000000002924. PMID 30004918.
- Lorant T, Bengtsson M, Eich T, Eriksson BM, Winstedt L, Järnum S, et al. (November 2018). “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. doi:10.1111/ajt.14733. PMC 6221156. PMID 29561066.
External links
- “Imlifidase”. Drug Information Portal. U.S. National Library of Medicine.
| Clinical data | |
|---|---|
| Pronunciation | im lif’ i dase |
| Trade names | Idefirix |
| Other names | HMED-IdeS |
| Routes of administration |
Intravenous |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C1575H2400N422O477S6 |
| Molar mass | 35071.36 g·mol−1 |
//////////Imlifidase, Idefirix, PEPTIDE, イムリフィダーゼ , 2020 APPROVALS, EMA 2020, EU 2020
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