Lebrikizumab, sold under the brand name Ebglyss is a

humanized monoclonal antibody Humanized antibodies are antibodies from non-human species whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans. The process of "humanization" is usually applied to monoclonal ant ...

used for the treatment of

atopic dermatitis Atopic dermatitis (AD), also known as atopic eczema, is a long-term type of inflammation of the skin. Atopic dermatitis is also often called simply eczema but the same term is also used to refer to dermatitis, the larger group of skin conditi ...

(atopic eczema). It is an interleukin-13 antagonist. It is given by

subcutaneous injection Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion. A subcutaneous injection is administered as a bolus (medicine), bolus into the subcutis, the layer of skin directly below the dermis and ...

. The most common side effects include injection site reactions, dry eye and conjunctivitis (redness and discomfort in the eye) including allergic conjunctivitis. Lebrikizumab was approved for medical use in the European Union in November 2023, in Canada in June 2024, and in the United States in September 2024.fda.gov
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Medical uses

Lebrikizumab is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents twelve years and older with a body weight of at least who are candidates for systemic therapy.

Mechanism of action

Lebrikizumab blocks

interleukin 13 Interleukin 13 (IL-13) is a protein that in humans is encoded by the ''IL13'' gene. IL-13 was first cloned in 1993 and is located on chromosome 5q31.1 with a length of 1.4kb. It has a mass of 13 kDa and folds into 4 alpha helical bundles. The sec ...

(IL-13), a

cytokine Cytokines () are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are produced by a broad range of cells, including immune cells like macrophages, B cell, B lymphocytes, T cell, T lymphocytes ...

(cell-signalling protein) that is produced by a type of

white blood cell White blood cells (scientific name leukocytes), also called immune cells or immunocytes, are cells of the immune system that are involved in protecting the body against both infectious disease and foreign entities. White blood cells are genera ...

called Th2 cells. IL-13 is thought to induce the expression of another signalling protein,

periostin Periostin (POSTN, PN, or osteoblast-specific factor OSF-2) is a protein that in humans is encoded by the ''POSTN'' gene. Periostin functions as a ligand for alpha-v beta-3, alpha-V/beta-3 and alpha-v beta-5, alpha-V/beta-5 integrins to support c ...

, by

epithelial cell Epithelium or epithelial tissue is a thin, continuous, protective layer of Cell (biology), cells with little extracellular matrix. An example is the epidermis, the outermost layer of the skin. Epithelial (Mesothelium, mesothelial) tissues line ...

s of the

bronchi A bronchus ( ; : bronchi, ) is a passage or airway in the lower respiratory tract that conducts air into the lungs. The first or primary bronchi to branch from the trachea at the carina are the right main bronchus and the left main bronchus. Thes ...

. Periostin in turn seems to partake in a number of asthma related problems, such as

bronchial hyperresponsiveness Bronchial hyperresponsiveness (or other combinations with airway or hyperreactivity, BH used as a general abbreviation) is a state characterised by easily triggered bronchospasm (contraction of the bronchioles or small airways). Bronchial hyperres ...

, inflammation, and activation and

proliferation Proliferation may refer to: Weapons *Nuclear proliferation, the spread of nuclear weapons, material, and technology *Chemical weapon proliferation, the spread of chemical weapons, material, and technology *Missile proliferation, the spread of lon ...

of airway

fibroblast A fibroblast is a type of cell (biology), biological cell typically with a spindle shape that synthesizes the extracellular matrix and collagen, produces the structural framework (Stroma (tissue), stroma) for animal Tissue (biology), tissues, and ...

s, which are involved in airway remodelling. 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.

Society and culture

Legal status

In September 2023, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

recommended authorizing lebrikizumab (Ebglyss) for the treatment of atopic dermatitis. Lebrikizumab was authorized for medical use in the European Union in November 2023. In September 2023, the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(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. Lebrikizumab was approved by the FDA in September 2024.

Brand names

Lebrikizumab is the international nonproprietary name. Lebrikizumab is sold under the brand name Ebglyss.

Research

Lebrikizumab is under investigation as an

immunosuppressive medication Immunosuppressive drugs, also known as immunosuppressive agents, immunosuppressants and antirejection medications, are drugs that inhibit or prevent the activity of the immune system. Classification Immunosuppressive drugs can be classified ...

for the treatment of

asthma Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wh ...

that cannot be adequately controlled with inhalable

glucocorticoid Glucocorticoids (or, less commonly, glucocorticosteroids) are a class of corticosteroids, which are a class of steroid hormones. Glucocorticoids are corticosteroids that bind to the glucocorticoid receptor that is present in almost every vertebra ...

s. It was created by

Tanox Tanox was a biopharmaceutical company based in Houston, Texas. The company was founded by two biomedical research scientists, Nancy T. Chang and Tse Wen Chang in March 1986 with $250,000, which was a large part of their family savings at that ti ...

under the code name TNX-650, and a phase I

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

for refractory

Hodgkin’s lymphoma Hodgkin lymphoma (HL) is a type of lymphoma in which cancer originates from a specific type of white blood cell called lymphocytes, where multinucleated Reed–Sternberg cells (RS cells) are present in the lymph nodes. The condition was named a ...

had been performed when

Genentech Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche. Genentech Research and Early Development operates as an independent cent ...

acquired Tanox in 2007. It has successfully completed a phase II clinical trial for the treatment of asthma.

References

{{Authority control Anti-interleukin monoclonal antibodies Drugs developed by Genentech Drugs developed by Hoffmann-La Roche Immunosuppressants