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Lebrikizumab

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Lebrikizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetIL-13
Clinical data
Trade namesEbglyss
Other namesMILR1444A, RG3637, TNX-650, lebrikizumab-lbkz
AHFS/Drugs.comEbglyss
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6434H9972N1700O2034S50
Molar mass145287.42 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Lebrikizumab, sold under the brand name Ebglyss is a humanized monoclonal antibody used for the treatment of atopic dermatitis (atopic eczema).[7][8] It is an interleukin-13 antagonist.[7] It is given by subcutaneous injection.[7]

The most common side effects include injection site reactions, dry eye and conjunctivitis (redness and discomfort in the eye) including allergic conjunctivitis.[8]

Lebrikizumab was approved for medical use in the European Union in November 2023,[8] in Canada in June 2024,[5] and in the United States in September 2024 to treat moderate-to-severe atopic dermatitis.[10][11][12]

Medical uses

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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 40 kilograms (88 lb) who are candidates for systemic therapy.[8]

Mechanism of action

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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.[13][14]

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.[15]

Society and culture

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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.[16] Lebrikizumab was authorized for medical use in the European Union in November 2023.[8]

In September 2023, the US Food and Drug Administration (FDA) 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.[17] Lebrikizumab was approved by the FDA in September 2024.[11][12][10]

Brand names

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Lebrikizumab is the international nonproprietary name.[18]

Lebrikizumab is sold under the brand name Ebglyss.[8]

Research

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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.[19][20][21] It has successfully completed a phase II clinical trial for the treatment of asthma.[13]

References

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  1. ^ "Ebglyss (lebrikizumab)". Therapeutic Goods Administration (TGA). 23 June 2024. Retrieved 7 July 2024.
  2. ^ "Ebglyss (Eli Lilly Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 1 July 2024. Archived from the original on 7 July 2024. Retrieved 7 July 2024.
  3. ^ "Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024". Federal Register of Legislation. 30 May 2024. Archived from the original on 10 June 2024. Retrieved 10 June 2024.
  4. ^ "Register Of Innovative Drugs [Updated: 2024-07-04]". Health Canada. 4 July 2024. Retrieved 15 July 2024.
  5. ^ a b "Ebglyss Product information". Health Canada. 24 June 2024. Retrieved 15 July 2024.
  6. ^ "Regulatory Decision Summary for Ebglyss (lebrikizumab)". Drug and Health Products Portal. 24 June 2024. Retrieved 27 December 2024.
  7. ^ a b c d "Ebglyss- lebrikizumab-lbkz injection, solution". DailyMed. 19 September 2024. Retrieved 5 October 2024.
  8. ^ a b c d e f g "Ebglyss EPAR". European Medicines Agency (EMA). 21 November 2023. Archived from the original on 22 November 2023. Retrieved 22 November 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ "Ebglyss Product information". Union Register of medicinal products. 17 November 2023. Archived from the original on 26 November 2023. Retrieved 11 December 2023.
  10. ^ a b "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
  11. ^ a b https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761306Orig1s000correctedltr.pdf
  12. ^ a b "FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis" (Press release). Eli Lilly. 13 September 2024. Retrieved 17 September 2024 – via PR Newswire.
  13. ^ a b Kraft M (September 2011). "Asthma phenotypes and interleukin-13--moving closer to personalized medicine". The New England Journal of Medicine. 365 (12): 1141–4. doi:10.1056/NEJMe1108666. PMC 4390041. PMID 21879891.
  14. ^ "Prous Science Molecule of the Month: Lebrikizumab". Thomson Reuters. October 2011. Archived from the original on 26 October 2011. Retrieved 15 December 2011.
  15. ^ Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, et al. (September 2011). "Lebrikizumab treatment in adults with asthma". The New England Journal of Medicine. 365 (12): 1088–98. doi:10.1056/NEJMoa1106469. PMID 21812663.
  16. ^ "Ebglyss: Pending EC decision". European Medicines Agency. 15 September 2023. Archived from the original on 20 September 2023. Retrieved 24 September 2023.
  17. ^ "FDA Rejects Lilly's Eczema Treatment Over Third-Party Manufacturing Issues". BioSpace. 2 October 2023. Retrieved 3 October 2023.
  18. ^ World Health Organization (2010). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 63". WHO Drug Information. 24 (1). hdl:10665/74530.
  19. ^ "First Patient Dosed In Phase 1 Trial Of Tanox, Inc.'s TNX-650 - News, Search Jobs, Events". Archived from the original on 3 March 2016. Retrieved 8 July 2008.
  20. ^ "anti-IL-13 humanized monoclonal antibody TNX-650". NCI Drug Dictionary. National Cancer Institute. Archived from the original on 25 September 2009. Retrieved 10 December 2009.
  21. ^ Clinical trial number NCT00441818 for "Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma" at ClinicalTrials.gov
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