Lebrikizumab Explained

Verifiedfields:changed
Watchedfields:changed
Verifiedrevid:458270514
Type:mab
Mab Type:mab
Source:zu
Target:IL-13
Tradename:Ebglyss
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Subcutaneous
Atc Prefix:D11
Atc Suffix:AH10
Legal Au:S4
Legal Au Comment:[2] [3]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[4] [5]
Legal Eu:Rx-only
Legal Eu Comment:[6] [7]
Cas Number:953400-68-5
Drugbank:DB11914
Chemspiderid:none
Unii:U9JLP7V031
Kegg:D09633
Synonyms:MILR1444A, RG3637, TNX-650
C:6434
H:9972
N:1700
O:2034
S:50

Lebrikizumab, sold under the brand name Ebglyss is a humanized monoclonal antibody used for the treatment of atopic dermatitis (atopic eczema).

The most common side effects include injection site reactions, dry eye and conjunctivitis (redness and discomfort in the eye) including allergic conjunctivitis.

It was approved for medical use in the European Union in November 2023.

Medical uses

Lebrikizumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents twelve years and older with a body weight of at least 40kg (90lb) who are candidates for systemic therapy.

Mechanism of action

Lebrikizumab blocks interleukin 13 (IL-13), a cytokine (cell-signalling protein) that is produced by a type of white blood cell called Th2 cells. IL-13 is thought to induce the expression of another signalling protein, periostin, by epithelial cells of the bronchi. Periostin in turn seems to partake in a number of asthma related problems, such as bronchial hyperresponsiveness, inflammation, and activation and proliferation of airway fibroblasts, which are involved in airway remodelling.[8]

This theory is supported by the fact that people with high periostin levels responded significantly better to lebrikizumab in the phase II study: the forced expiratory volume in 1 second (FEV1) was 8.2% higher than under placebo in this group (measured from the respective baselines), while low-periostin patients had 1.6% higher FEV1, and the average value for all patients was 5.5%. The FEV1 increase in low-periostin patients was not statistically significant.[9]

Society and culture

Legal status

In September 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended authorizing lebrikizumab (Ebglyss) for the treatment of atopic dermatitis.[10] Lebrikizumab was approved for medical use in the European Union in November 2023.

In September 2023, the US Food and Drug Administration declined to approve lebrikizumab due to certain findings during an inspection of a contract manufacturer, unrelated to the clinical trial data, safety, or label for lebrikizumab.[11]

Brand names

Lebrikizumab is the international nonproprietary name.[12]

Lebrikizumab is sold under the brand name Ebglyss.

Research

Lebrikizumab is under investigation as an immunosuppressive medication for the treatment of asthma that cannot be adequately controlled with inhalable glucocorticoids. It was created by Tanox under the code name TNX-650, and a phase I clinical trial for refractory Hodgkin’s lymphoma had been performed when Genentech acquired Tanox in 2007.[13] [14] It has successfully completed a Phase II clinical trial for the treatment of asthma.[15]

Notes and References

  1. Web site: Ebglyss (lebrikizumab) . Therapeutic Goods Administration (TGA) . 23 June 2024 . 7 July 2024.
  2. Web site: Ebglyss (Eli Lilly Australia Pty Ltd) . Therapeutic Goods Administration (TGA) . 1 July 2024 . 7 July 2024 . 7 July 2024 . https://web.archive.org/web/20240707062736/https://www.tga.gov.au/resources/prescription-medicines-registrations/ebglyss-eli-lilly-australia-pty-ltd . live .
  3. Web site: Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 . Federal Register of Legislation . 30 May 2024 . 10 June 2024 . 10 June 2024 . https://web.archive.org/web/20240610054546/https://www.legislation.gov.au/F2024L00589/asmade/text . live .
  4. Web site: Register Of Innovative Drugs [Updated: 2024-07-04] ]. . 4 July 2024 . 15 July 2024.
  5. Web site: Ebglyss Product information . . 24 June 2024 . 15 July 2024.
  6. Web site: Ebglyss EPAR . European Medicines Agency (EMA) . 21 November 2023 . 22 November 2023 . 22 November 2023 . https://web.archive.org/web/20231122054717/https://www.ema.europa.eu/en/medicines/human/EPAR/ebglyss . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. Web site: Ebglyss Product information . Union Register of medicinal products . 17 November 2023 . 11 December 2023 . 26 November 2023 . https://web.archive.org/web/20231126162556/https://ec.europa.eu/health/documents/community-register/html/h1765.htm . live .
  8. Web site: Prous Science Molecule of the Month: Lebrikizumab . October 2011 . . 15 December 2011 . 26 October 2011 . https://web.archive.org/web/20111026031238/http://www.prous.com/molecules/default.asp?ID=214 . live .
  9. Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG . Lebrikizumab treatment in adults with asthma . The New England Journal of Medicine . 365 . 12 . 1088–98 . September 2011 . 21812663 . 10.1056/NEJMoa1106469 . free .
  10. Web site: Ebglyss: Pending EC decision . European Medicines Agency . 15 September 2023 . 24 September 2023 . 20 September 2023 . https://web.archive.org/web/20230920140531/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ebglyss . live .
  11. Web site: FDA Rejects Lilly's Eczema Treatment Over Third-Party Manufacturing Issues . 3 October 2023 . BioSpace . 2 October 2023 .
  12. ((World Health Organization)) . 2010 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 63 . WHO Drug Information . 24 . 1 . 10665/74530 . free . World Health Organization .
  13. Web site: First Patient Dosed In Phase 1 Trial Of Tanox, Inc.'s TNX-650 - News, Search Jobs, Events . 8 July 2008 . 3 March 2016 . https://web.archive.org/web/20160303234012/http://www.biospace.com/news_story.aspx?NewsEntityId=19463 . dead .
  14. Web site: anti-IL-13 humanized monoclonal antibody TNX-650. NCI Drug Dictionary. National Cancer Institute. 10 December 2009. 25 September 2009. https://web.archive.org/web/20090925230803/http://www.cancer.gov/drugdictionary/?CdrID=539362. live.
  15. Kraft M . Asthma phenotypes and interleukin-13--moving closer to personalized medicine . The New England Journal of Medicine . 365 . 12 . 1141–4 . September 2011 . 21879891 . 4390041 . 10.1056/NEJMe1108666 .

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