Back دوبيلوماب Arabic Dupilumab German Dupilumab Spanish دوپیلوماب Persian Dupilumab French デュピルマブ Japanese ଡୁପିଲୁମାବ OR Dupilumabe Portuguese Дупилумаб Russian Дупілумаб Ukrainian

Dupilumab

Dupilumab
3D structure of dupilumab's antigen binding fragment complexed with a human IL-4 receptor sub-unit alpha
Dupilumab antigen binding fragment (orange and green) bound to a human IL-4 receptor alpha (purple)
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetInterleukin 4 (IL4) receptor alpha
Clinical data
Pronunciation/duˈpɪljumæb/ doo-PIL-yoo-mab
Trade namesDupixent
AHFS/Drugs.comMonograph
MedlinePlusa617021
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6512H10066N1730O2052S46
Molar mass146898.98 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]

  1. ^ a b "AusPAR: Dupilumab". Therapeutic Goods Administration (TGA). 4 May 2022. Retrieved 4 May 2022.
  2. ^ "Regulatory Decision Summary for Dupixent". Drug and Health Products Portal. 14 April 2023. Retrieved 2 April 2024.
  3. ^ "Skin health". Health Canada. 9 May 2018. Retrieved 13 April 2024.
  4. ^ a b c "Dupixent- dupilumab injection, solution". DailyMed. 25 June 2020. Archived from the original on 24 March 2021. Retrieved 17 September 2020.
  5. ^ a b "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.
  6. ^ "Statement on a Nonproprietary Name Adopted By The USAN Council - Dupilumab" Archived 21 May 2021 at the Wayback Machine, American Medical Association.
  7. ^ a b "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.
  8. ^ "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.
  9. ^ a b c d e f Cite error: The named reference FDA PR 20220520 was invoked but never defined (see the help page).
  10. ^ a b c Cite error: The named reference FDA PR 20220929 was invoked but never defined (see the help page).
  11. ^ "Sanofi - Commercial collaboration". Sanofi. Archived from the original on 8 November 2017. Retrieved 9 March 2017.
  12. ^ "A powerful research and development engine". www.regeneron.com. Archived from the original on 30 April 2019. Retrieved 9 March 2017.
  13. ^ 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.

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