Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized |
Target | Interleukin-31 receptor A |
Clinical data | |
Trade names | Nemluvio |
Other names | CIM-331, CD14152, nemolizumab-ilto |
AHFS/Drugs.com | Monograph |
MedlinePlus | a624059 |
License data |
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Routes of administration | Subcutaneous injection |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Metabolism | Proteolytic enzymes |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG |
Nemolizumab, sold under the brand name Nemluvio, is a humanized monoclonal antibody used for the treatment of prurigo nodularis and atopic dermatitis. [1] It is a monoclonal antibody that blocks the interleukin-31 receptor A. [1] [2] Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha. [3] It is an interleukin-31 receptor antagonist. [1] IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis. [3] By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines. [3]
Nemolizumab was approved for medical use in the United States in August 2024. [2] [4] [5]
Nemolizumab is indicated for the treatment of adults with prurigo nodularis. [1] [2] In December 2024, the indication for nemolizumab was updated to include the treatment of people twelve years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. [1] [2] [6]
Nemolizumab was invented by Chugai, who sold an exclusive license for the drug's development and worldwide marketing (except Japan and Taiwan) to Galderma in 2016. [7]
The US Food and Drug Administration (FDA) approved nemolizumab for the treatment of prurigo nodularis based on evidence from two clinical trials (OLYMPIA 1 and OLYMPIA 2) of 560 participants with prurigo nodularis. [2] The trials were conducted at 132 sites in 16 countries including Austria, Belgium, Canada, Denmark, France, Netherlands, Germany, Hungary, Italy, Poland, South Korea, Spain, Sweden, Switzerland, the United Kingdom, and the United States. [2] The trials included 99 participants inside the United States. [2] Among the 560 enrolled participants, all of them were evaluated for efficacy (intent-to-treat population) and 556 participants were evaluated for safety. [2] In both trials, participants with prurigo nodularis were randomized to receive nemolizumab or placebo. [2] Participants weighing less than 90 kilograms (200 lb) in the nemolizumab group received subcutaneous injections of nemolizumab 60 mg at week 0, followed by 30 mg injections every four weeks. [2] Participants weighing 90 kilograms (200 lb) or more in the nemolizumab group received subcutaneous injections of nemolizumab 60 mg at week 0 and every four weeks. [2]
Nemolizumab was approved for medical use in the United States in August 2024. [2] [4] [5] [8]
In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Nemluvio, intended for the treatment of atopic dermatitis and prurigo nodularis. [3] The applicant for this medicinal product is Galderma International. [3] [9]
Nemolizumab is the international nonproprietary name. [10]
Nemolizumab is sold under the brand name Nemluvio. [2]
Galderma S.A. is a Swiss pharmaceutical company specializing in dermatological treatments and skin care products. Formerly a subsidiary of L'Oréal and Nestlé, it has been held by a consortium of private institutional investors since 2019.
Prurigo nodularis (PN), also known as nodular prurigo, is a skin disorder characterized by pruritic (itchy), nodular lesions, which commonly appear on the trunk, arms and legs. Patients often present with multiple excoriated nodules caused by chronic scratching. Although the exact cause of PN is unknown, PN is associated with other dermatologic conditions such as untreated or severe atopic dermatitis and systemic causes of pruritus including liver disease and end stage kidney disease. The goal of treatment in PN is to decrease itching. PN is also known as Hyde prurigo nodularis, or Picker's nodules.
Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company branched out into the study of both cytokine and tyrosine kinase receptors, which gave rise to their first product, which is a VEGF-trap.
Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis. It is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and is an immunosuppressive drug. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds. It is administered by intravenous infusion. The fixed-dose combination ocrelizumab/hyaluronidase is administered by subcutaneous injection.
Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche.
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Satralizumab, sold under the brand name Enspryng, is a humanized monoclonal antibody medication that is used for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease. The drug is being developed by Chugai Pharmaceutical, a subsidiary of Roche.
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