Chemistry:Lebrikizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | IL-13 |
| Clinical data | |
| Other names | MILR1444A, RG3637, TNX-650 |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6434H9972N1700O2034S50 |
| Molar mass | 145287.42 g·mol−1 |
  (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).[1]
The most common side effects include injection site reactions, dry eye and conjunctivitis (redness and discomfort in the eye) including allergic conjunctivitis.[1]
It was approved for medical use in the European Union in November 2023.[1]
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 40 kilograms (88 lb) who are candidates for systemic therapy.[1]
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.[3][4]
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.[5]
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.[6] Lebrikizumab was approved for medical use in the European Union in November 2023.[1]
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.[7]
Brand names
Lebrikizumab is the international nonproprietary name.[8]
Lebrikizumab is sold under the brand name Ebglyss.[1]
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.[9][10][11] It has successfully completed a Phase II clinical trial for the treatment of asthma.[12][3]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Ebglyss EPAR". 21 November 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/ebglyss. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Ebglyss Product information". 17 November 2023. https://ec.europa.eu/health/documents/community-register/html/h1765.htm.
- ↑ 3.0 3.1 "Asthma phenotypes and interleukin-13--moving closer to personalized medicine". The New England Journal of Medicine 365 (12): 1141–4. September 2011. doi:10.1056/NEJMe1108666. PMID 21879891.
- ↑ "Prous Science Molecule of the Month: Lebrikizumab". Thomson Reuters. October 2011. http://www.prous.com/molecules/default.asp?ID=214.
- ↑ "Lebrikizumab treatment in adults with asthma". The New England Journal of Medicine 365 (12): 1088–98. September 2011. doi:10.1056/NEJMoa1106469. PMID 21812663.
- ↑ "Ebglyss: Pending EC decision". 15 September 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ebglyss.
- ↑ "FDA Rejects Lilly's Eczema Treatment Over Third-Party Manufacturing Issues". https://www.biospace.com/article/fda-rejects-lilly-s-eczema-treatment-over-third-party-manufacturing-issues/.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 63". WHO Drug Information 24 (1). 2010.
- ↑ "First Patient Dosed In Phase 1 Trial Of Tanox, Inc.'s TNX-650 - News, Search Jobs, Events". http://www.biospace.com/news_story.aspx?NewsEntityId=19463.
- ↑ "anti-IL-13 humanized monoclonal antibody TNX-650". NCI Drug Dictionary. National Cancer Institute. http://www.cancer.gov/drugdictionary/?CdrID=539362.
- ↑ Clinical trial number NCT00441818 for "Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma" at ClinicalTrials.gov
- ↑ Clinical trial number NCT00930163 for "A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids (MILLY)" at ClinicalTrials.gov
 |  |
