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Nemolizumab
Nemolizumab, sold under the brand name Nemluvio, is a humanized monoclonal antibody used for the treatment of prurigo nodularis and atopic dermatitis. It is a monoclonal antibody that blocks the interleukin-31 receptor A. Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha. It is an interleukin-31 receptor antagonist. IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis. By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines. Nemolizumab was approved for medical use in the United States in August 2024, and in the European Union in February 2025. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses Nemolizumab is indicated for the treatment of adults with prurigo nodularis. In December 2024, the indication for nemolizumab was updated t ...
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Galderma
Galderma SA is an American-Swiss pharmaceutical company specializing in dermatological treatments and skin care products. Formerly a subsidiary of L'Oréal and Nestlé, it was acquired by a consortium of private institutional investors in 2019 and remained under their ownership until its IPO in 2024. Galderma was formed in 1981 as a joint venture between Nestlé and L'Oréal, and later became a wholly owned subsidiary of Nestlé. Since 2019, it has belonged to an investment consortium. The company, headed by president and CEO Flemming Ørnskov (ex-Shire), has 33 sites in 100 countries with a worldwide network of distributors and employs more than 4,600 people. The headquarters is based in Zug, Switzerland. History The origins of Galderma date back to 1961 and the founding of the Owen dermatology company in Dallas, Texas, USA by M. Owen. In 1979, Hans Schaefer founded the International Center for Dermatological Research (CIRD) in Sophia Antipolis, with the support of t ...
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Prurigo Nodularis
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.'' Signs and symptoms * Nodules are discrete, generally symmetric, hyperpigmented and firm. They are greater than 0.5 cm in both width and depth (as opposed to papules which are less than 0.5 cm). * The nodules of PN can appear on any part of the body, but generally are found in areas where patients are able to reach to scratch. Patients can exhibit a 'butterfly sign ...
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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 conditions. Atopic dermatitis results in puritis, itchy, red, swollen, and cracked skin. Clear fluid may come from the affected areas, which can thicken over time. Atopic dermatitis affects about 20% of people at some point in their lives. It is more common in younger children. Females are affected slightly more often than males. Many people outgrow the condition. While the condition may occur at any age, it typically starts in childhood, with changing severity over the years. In children under one year of age, the face and limbs and much of the body may be affected. As children get older, the areas on the insides of the knees and folds of the elbows and around the neck are most commonly affected. In adults, the hands and feet are commonly affec ...
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Interleukin-31 Receptor A
Interleukin-31 receptor A is a protein that in humans is encoded by the ''IL31RA'' gene In biology, the word gene has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei .... IL31RA is related to gp130 (IL6ST; MIM 600694), the common receptor subunit for IL6 (MIM 147620)-type cytokines. Oncostatin M receptor (OSMR; MIM 601743) and IL31RA form the heterodimeric receptor through which IL31 (MIM 609509) signals. Expression of IL31RA and OSMR mRNA is induced in activated monocytes, and both mRNAs are constitutively expressed in epithelial cells (Dillon et al., 2004). upplied by OMIMref name="entrez"> References Further reading

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Calcineurin Inhibitor
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 into five groups: * glucocorticoids * cytostatics * antibodies * drugs acting on immunophilins * other drugs Glucocorticoids In pharmacologic (supraphysiologic) doses, glucocorticoids, such as prednisone, dexamethasone, and hydrocortisone are used to suppress various allergic, inflammatory, and autoimmune disorders. They are also administered as posttransplantory immunosuppressants to prevent the acute transplant rejection and graft-versus-host disease. Nevertheless, they do not prevent an infection and also inhibit later reparative processes. Immunosuppressive mechanism Glucocorticoids suppress cell-mediated immunity. They act by inhibiting gene expression of cytokines including Interleukin 1 (IL-1), IL-2, IL-3, IL-4, IL-5, I ...
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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 or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ...
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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 regarding medicinal product Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...s for human use. See also * Committee for Medicinal Products for Veterinary Use References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ...
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Breakthrough Therapy
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review. Requirements A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination wit ...
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Chugai
is a drug manufacturer operating in Japan. It is a subsidiary controlled by Hoffmann-La Roche, which owns 62% of the company as of 30 June 2014. The company is headquartered in Tokyo. Osamu Nagayama is the current representative director and chairman. Tatsuro Kosaka is the current representative director, president and CEO. History Timeline This is a timeline of important events of Chugai Pharmaceutical. * 1925: Juzo Ueno founded Chugai Shinyaku Co. Ltd. and started importing and selling medicines * 1927: Start of the first own production * 1930: Salobrocanon, an analgesic (pain reliever ) and antipyretic, is launched * 1937: Calcium bromide production begins * 1943: Name changed to Chugai Pharmaceutical Co., Ltd. based in Tokyo * 1944: Acquisition of Matsunaga Pharmaceutical Ltd. and construction of a plant in Matsunaga * 1945: The headquarters, the factories in Ikebukuro, Sakai and Takada were destroyed in World War II, the headquarters were relocated to Takada, the factor ...
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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 is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits. In the United States, indications for prescription drugs are approved by the FDA. Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof ...
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Corticosteroid
Corticosteroids are a class of steroid hormones that are produced in the adrenal cortex of vertebrates, as well as the synthetic analogues of these hormones. Two main classes of corticosteroids, glucocorticoids and mineralocorticoids, are involved in a wide range of physiological processes, including stress response, immune response, and regulation of inflammation, carbohydrate metabolism, protein catabolism, blood electrolyte levels, and behavior. Some common naturally occurring steroid hormones are cortisol (), corticosterone (), cortisone () and aldosterone () (cortisone and aldosterone are isomers). The main corticosteroids produced by the adrenal cortex are cortisol and aldosterone. The etymology of the '' cortico-'' part of the name refers to the adrenal cortex, which makes these steroid hormones. Thus a corticosteroid is a "cortex steroid". Classes * Glucocorticoids such as cortisol affect carbohydrate, fat, and protein metabolism, and have anti ...
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