Therapeutic Dupilumab antibody from the original Dupixent® commercial drug
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|API type||Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.|
|Pharmacotherapeutic group||Other dermatological preparations, agents for dermatitis, excluding corticosteroids|
|Target of antibody||IL-13, IL-4|
|General function||Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and |
adolescents 12 years and older who are candidates for systemic therapy. Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for
severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised
fraction of exhaled nitric oxide (FeNO).
(Mechanism of action; Source EMA document)
|Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis, asthma, and CRSwNP. Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.|
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||In atopic dermatitis clinical trials, treatment with dupilumab was associated with decreases from baseline in concentrations of type 2 immunity biomarkers, such as thymus and activation-regulated chemokine (TARC/CCL17), total serum IgE and allergen-specific IgE in serum. A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment in adults and adolescents with atopic dermatitis. In asthma clinical trials, dupilumab treatment markedly decreased FeNO and circulating |
concentrations of eotaxin-3, total IgE, allergen specific IgE, TARC, and periostin in asthma subjects.
relative to placebo
|Original license holder|
|Marketing authorisation numbers||EU/1/17/1229/002|
|Marketing authorisation holder||sanofi-aventis groupe 54, rue La Boétie 75008 Paris France|
|Name of the manufacturer of the biological active substance||REGENERON PHARMACEUTICALS INC. 81 Columbia Turnpike RENSSELAER NEW YORK 12144 UNITED STATES; Regeneron Ireland Designated Activity Company (DAC) Ballycummin Raheen Business Park Limerick Ireland; Genzyme Flanders BVBA Cipalstraat 8, B-2440 Geel Belgium|
|Name and address of the manufacturer(s) responsible for batch release||SANOFI WINTHROP INDUSTRIE 1051 Boulevard Industriel, 76580 LE TRAIT, FRANCE; Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 Industriepark Hoechst 65926 FRANKFURT AM MAIN GERMANY|
|Max shelf life||3 years|
|Storage conditions||2°C - 8°C|
|List of excipients||arginine hydrochloride - histidine - polysorbate 80 (E433) - sodium acetate trihydrate - glacial acetic acid (E260) - sucrose - water for injections|
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