Nemolizumab

Last updated

Nemolizumab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target Interleukin-31 receptor A
Clinical data
Trade names Nemluvio
Other namesCIM-331, CD14152, nemolizumab-ilto
AHFS/Drugs.com Monograph
MedlinePlus a624059
License data
Routes of
administration
Subcutaneous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolism Proteolytic enzymes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
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]

Contents

Nemolizumab was approved for medical use in the United States in August 2024. [2] [4] [5]

Medical uses

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]

History

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]

Society and culture

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]

Names

Nemolizumab is the international nonproprietary name. [10]

Nemolizumab is sold under the brand name Nemluvio. [2]

Related Research Articles

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.

<span class="mw-page-title-main">Prurigo nodularis</span> Medical condition

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.

<span class="mw-page-title-main">Regeneron Pharmaceuticals</span> American biotechnology company

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.

Mepolizumab, sold under the brand name Nucala by GlaxoSmithKline, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome (HES). It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.

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

Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human monoclonal antibody designed for the treatment of inflammatory diseases.

Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of autoimmune diseases. Chemically, it is a form of a humanized monoclonal antibody. The substance acts by binding interleukin 17A and neutralizing it, reducing inflammation.

<span class="mw-page-title-main">Tralokinumab</span> Monoclonal antibody

Tralokinumab sold under the brand names Adtralza (EU/UK) and Adbry (US) among others, is a human monoclonal antibody used for the treatment of atopic dermatitis. Tralokinumab targets the cytokine interleukin 13.

<span class="mw-page-title-main">Dupilumab</span> Drug used to treat allergic diseases

Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. It is also used for the treatment of eosinophilic esophagitis, prurigo nodularis and COPD.

Tildrakizumab, sold under the brand name Ilumya among others, is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. It is approved for the treatment of adults with moderate-to-severe plaque psoriasis in the United States and in the European Union.

<span class="mw-page-title-main">Crisaborole</span> Chemical compound

Crisaborole, sold under the brand name Eucrisa among others, is a nonsteroidal topical medication used for the treatment of mild-to-moderate atopic dermatitis (eczema) in adults and children.

Risankizumab, sold under the brand name Skyrizi, is a humanized monoclonal antibody used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is designed to target interleukin 23A (IL-23A). It is given by subcutaneous injection.

Bimekizumab, sold under the brand name Bimzelx, is a humanized anti-IL17A, anti-IL-17F, and anti-IL17AF monoclonal antibody that is used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis and hidradenitis suppurativa.

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.

<span class="mw-page-title-main">Abrocitinib</span> Chemical compound

Abrocitinib, sold under the brand name Cibinqo, is a medication used for the treatment of atopic dermatitis (eczema). It is a Janus kinase inhibitor and it was developed by Pfizer. It is taken by mouth.

<span class="mw-page-title-main">Casirivimab/imdevimab</span> Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.

Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL-36R) antagonist. It is given via injection into a vein.

Vixarelimab (KPL-716) is a fully human monoclonal antibody that works by binding to the oncostatin M receptor β, thus inhibiting both interleukin 31 and oncostatin M. It is developed by Kiniksa Pharmaceuticals for prurigo nodularis.

References

  1. 1 2 3 4 5 6 "Nemluvio- nemolizumab-ilto injection, powder, lyophilized, for solution". DailyMed. 13 August 2024. Retrieved 5 September 2024.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 "Drug Trials Snapshots: Nemluvio". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 31 October 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 3 4 5 "Nemluvio EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 13 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. 1 2 "Drug Approval Package: Nemluvio". U.S. Food and Drug Administration (FDA). 10 September 2024. Retrieved 13 December 2024.
  5. 1 2 "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
  6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf
  7. "Chugai grants exclusive global license for development and marketing of nemolizumab to Galderma". Pharmabiz.com. 22 July 2016.
  8. "Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Adult Patients Living With Prurigo Nodularis" (Press release). Galderma. 13 August 2024. Retrieved 14 August 2024 via Business Wire.
  9. "CHMP recommends approval of Galderma's nemolizumab for moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union". Galderma (Press release). 13 December 2024. Retrieved 13 December 2024.
  10. World Health Organization (2015). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74". WHO Drug Information. 29 (3). hdl: 10665/331070 .

Further reading