Dupilumab antigen binding fragment (orange and green) bound to a human IL-4 receptor alpha (purple)
Monoclonal antibody
Type
Whole antibody
Source
Human
Target
Interleukin 4 (IL4) receptor alpha
Clinical data
Pronunciation
/duˈpɪljumæb/doo-PIL-yoo-mab
Trade names
Dupixent
AHFS/Drugs.com
Monograph
MedlinePlus
a617021
License data
US DailyMed: Dupilumab
Pregnancy category
AU: B1[1]
Routes of administration
Subcutaneous
ATC code
D11AH05 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[1]
CA: ℞-only[2][3]
US: ℞-only[4]
EU: Rx only[5]
Identifiers
CAS Number
1190264-60-8
DrugBank
DB12159
ChemSpider
none
UNII
420K487FSG
KEGG
D10354
Chemical and physical data
Formula
C6512H10066N1730O2052S46
Molar mass
146898.98 g·mol−1
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.[6][7][8][4] It is also used for the treatment of eosinophilic esophagitis[9] and prurigo nodularis.[10]
The most common side effects reported by the US Food and Drug Administration (FDA) include injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections.[9] The most common side effects reported by the European Medicines Agency (EMA) include injection-site reactions (such as redness, swelling including due to fluid build-up, itching and pain), conjunctivitis (redness and discomfort in the eye) including conjunctivitis due to allergy, joint pain, cold sores, and increased blood levels of a type of white blood cell called eosinophils.[5] It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme.[11][12] It received approval from the US Food and Drug Administration (FDA) for moderate-to-severe atopic dermatitis in 2017,[7] and for asthma in 2018.[4] The FDA considers it to be a first-in-class medication.[13]
Dupilumab is the first treatment for eosinophilic esophagitis approved by the U.S. Food and Drug Administration (FDA).[9] Eosinophilic esophagitis is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus.[9] In adults and adolescents with eosinophilic esophagitis, common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus.[9] Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.[9] Dupilumab is the first treatment for prurigo nodularis approved by the FDA.[10] Prurigo nodularis is a rare skin disease that causes hard, itchy lumps (nodules) to form on the skin.[10]
^ ab"AusPAR: Dupilumab". Therapeutic Goods Administration (TGA). 4 May 2022. Retrieved 4 May 2022.
^"Regulatory Decision Summary for Dupixent". Drug and Health Products Portal. 14 April 2023. Retrieved 2 April 2024.
^"Skin health". Health Canada. 9 May 2018. Retrieved 13 April 2024.
^ abc"Dupixent- dupilumab injection, solution". DailyMed. 25 June 2020. Archived from the original on 24 March 2021. Retrieved 17 September 2020.
^ ab"Dupixent EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 28 December 2021. Retrieved 23 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"Statement on a Nonproprietary Name Adopted By The USAN Council - Dupilumab" Archived 21 May 2021 at the Wayback Machine, American Medical Association.
^ ab"FDA approves new eczema drug Dupixent". U.S. Food and Drug Administration (FDA). 10 September 2019. Archived from the original on 28 March 2017. Retrieved 29 March 2017.
^"FDA approves first treatment for chronic rhinosinusitis with nasal polyps". U.S. Food and Drug Administration (FDA). 26 June 2019. Archived from the original on 29 December 2020. Retrieved 27 June 2019.
^ abcdefCite error: The named reference FDA PR 20220520 was invoked but never defined (see the help page).
^ abcCite error: The named reference FDA PR 20220929 was invoked but never defined (see the help page).
^"Sanofi - Commercial collaboration". Sanofi. Archived from the original on 8 November 2017. Retrieved 9 March 2017.
^"A powerful research and development engine". www.regeneron.com. Archived from the original on 30 April 2019. Retrieved 9 March 2017.
^New Drug Therapy Approvals 2017 (PDF) (Report). U.S. Food and Drug Administration (FDA). January 2018. Archived from the original on 23 October 2020. Retrieved 16 September 2020.
Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as...
are still limitations to the use of anti-IL-13 monoclonal antibodies. Dupilumab is a newer drug that targets the shared receptor of IL-4 and IL-13, IL4Rα...
have showed that abrocitinib improved the EASI scores in comparison with dupilumab, even in the second week of treatment. A faster onset of Investigator's...
inhibits PDGF-BB in hypereosinophilic leukemia Monoclonal antibodies such as dupilumab and lebrikizumab target IL-13 and its receptor, which reduces eosinophilic...
azathioprine, and methotrexate. Dupilumab is a new medication that improves eczema lesions, especially moderate to severe eczema. Dupilumab, a monoclonal antibody...
cases may need systemic medicines such as cyclosporin, methotrexate, dupilumab or baricitinib. Other names of the condition include "infantile eczema"...
July 2015, It is reported to cost $4,500 to $8,000 per year. Dupixent (dupilumab injection) is for the treatment of adolescent and adult patients' atopic...
for stable angina, marketed by Gilead Sciences. – Dermatology Dupixent (Dupilumab), for eczema, marketed by Regeneron. Dynabac (Dirithromycin), for acute...
nodularis is very hard to treat, but current therapies include steroids, dupilumab, vitamins, cryosurgery, thalidomide and UVB light[citation needed]. In...
year are unknown. Monoclonal antibody injections such as mepolizumab, dupilumab, or omalizumab may be useful in those with poorly controlled atopic asthma...
in symptoms. In May 2022, U.S. Food and Drug Administration approved dupilumab (Dupixent) to treat eosinophilic esophagitis (EoE) in adults and pediatric...
unknown origin. However, there are clinical trials currently underway with dupilumab which is thought to alleviate itch by acting on the IL-4 receptor on sensory...