Tralokinumab

Tralokinumab
Tralokinumab Fab fragment bound to IL-13. From PDB 5L6Y​.
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-13
Clinical data
Pronunciation/ˌtreɪləˈkɪnjʊmæb/
TRAY-lə-KIN-yuu-mab
Trade namesAdtralza, Adbry
Other namesCAT-354, tralokinumab-ldrm
License data
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6374H9822N1698O2014S44
Molar mass143875.20 g·mol−1
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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.[3][5] Tralokinumab targets the cytokine interleukin 13.[8]

The most common side effects include upper respiratory tract infections (colds and other infections of the nose and throat), reactions at the injection site, and redness and discomfort in the eye.[5]

Tralokinumab was approved for medical use in the European Union and in the United Kingdom in June 2021.[3][5][9] It was approved for medical use in the United States in December 2021.[7][10][4] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]

  1. ^ "Summary Basis of Decision (SBD) for Adtralza". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  2. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  3. ^ a b c "Adtralza 150 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 5 July 2021. Archived from the original on 9 July 2021. Retrieved 9 July 2021.
  4. ^ a b "Adbry- tralokinumab-ldrm injection, solution". DailyMed. Archived from the original on 13 January 2022. Retrieved 13 January 2022.
  5. ^ a b c d "Adtralza EPAR". European Medicines Agency (EMA). 20 April 2021. Archived from the original on 29 June 2021. Retrieved 9 July 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ "Adtralza Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  7. ^ a b Cite error: The named reference LEO Pharma PR was invoked but never defined (see the help page).
  8. ^ Kopf M, Bachmann MF, Marsland BJ (September 2010). "Averting inflammation by targeting the cytokine environment". Nature Reviews. Drug Discovery. 9 (9): 703–18. doi:10.1038/nrd2805. PMID 20811382. S2CID 23769909.
  9. ^ "LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis" (Press release). LEO Pharma. 22 June 2021. Archived from the original on 26 October 2021. Retrieved 22 January 2023 – via Business Wire.
  10. ^ "Drug Approval Package: Adbry". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 11 October 2022. Retrieved 22 January 2023.
  11. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.