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Tralokinumab

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.[7]

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][8] It was approved for medical use in the United States in December 2021.[9][4] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

Medical uses

Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.[5][3]

In the United States, tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.[4][11]

Discovery and development

Tralokinumab was discovered by Cambridge Antibody Technology scientists[12][13][14] using protein optimization based on Ribosome Display.[15] They used the extensive data sets from ribosome display to patent protect CAT-354 in a world-first of sequence-activity-relationship claims.[14] In 2004, clinical development of CAT-354 was initiated with this first study completing in 2005.[16] On 21 July 2011, MedImmune LLC initiated a Phase IIb, randomized, double-blind study to evaluate the efficacy of tralokinumab in adults with asthma.[17][18][19]

In 2016, MedImmune and AstraZeneca started developing tralokinumab for asthma (Phase III) and atopic dermatitis (Phase IIb) while clinical development for moderate-to-severe ulcerative colitis and idiopathic pulmonary fibrosis (IPF) have been discontinued.[16] In July of that year AstraZeneca licensed tralokinumab to Leo Pharma for skin diseases.[20]

A phase IIb study of tralokinumab found that treatment was associated with early and sustained improvements in atopic dermatitis symptoms and tralokinumab had an acceptable safety and tolerability profile, thereby providing evidence for targeting IL-13 in patients with atopic dermatitis.[21]

In June 2017, Leo Pharma started phase III clinical trials with tralokinumab in atopic dermatitis.[22]

Society and culture

Legal status

In April 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Adtralza, intended for the treatment of moderate‑to‑severe atopic dermatitis.[23] The applicant for this medicinal product is LEO Pharma A/S.[23] Tralokinumab was approved for medical use in the European Union in June 2021.[5]

Names

Tralokinumab is the international nonproprietary name (INN)[24] and the United States Adopted Name (USAN).[25]

References

  1. Summary Basis of Decision (SBD) for Adtralza Health Canada, 23 October 2014, 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. Adtralza 150 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) (emc), 5 July 2021, retrieved 9 July 2021^
  4. Adbry- tralokinumab-ldrm injection, solution DailyMed, retrieved 13 January 2022^
  5. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Adtralza EPAR European Medicines Agency (EMA), 20 April 2021, retrieved 9 July 2021^
  6. Adtralza Product information Union Register of medicinal products, retrieved 3 March 2023^
  7. Averting inflammation by targeting the cytokine environment Nature Reviews. Drug Discovery, September 2010^
  8. 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 LEO Pharma, 22 June 2021, retrieved 22 January 2023^
  9. Drug Approval Package: Adbry U.S. Food and Drug Administration (FDA), 25 January 2022, retrieved 22 January 2023^
  10. Advancing Health Through Innovation: New Drug Therapy Approvals 2021 U.S. Food and Drug Administration (FDA), 13 May 2022, retrieved 22 January 2023^
  11. LEO Pharma announces FDA approval of Adbry (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis LEO Pharma, 28 December 2021, retrieved 22 January 2023^
  12. Probing a protein-protein interaction by in vitro evolution Proceedings of the National Academy of Sciences of the United States of America, May 2006^
  13. Preclinical development of CAT-354, an IL-13 neutralizing antibody, for the treatment of severe uncontrolled asthma British Journal of Pharmacology, May 2012^
  14. Human Antibody Molecules for Il-13 retrieved 26 July 2015^
  15. Tailoring in vitro evolution for protein affinity or stability Proceedings of the National Academy of Sciences of the United States of America, January 2001^
  16. Tralokinumab Adis Insight, Springer Nature Switzerland AG, retrieved 20 February 2016^
  17. {{ClinicalTrialsGov|NCT01402986|A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Asthma}}^
  18. Pipeline MedImmune, retrieved 11 June 2013^
  19. Studies found for CAT-354 ClinicalTrials.gov, retrieved 11 June 2013^
  20. AstraZeneca enters licensing agreements with LEO Pharma in skin diseases July 2016, retrieved 13 March 2017^
  21. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb The Journal of Allergy and Clinical Immunology, January 2019^
  22. LEO Pharma starts phase 3 clinical study for tralokinumab in atopic dermatitis LEO Pharma, 1 July 2016, retrieved 31 July 2019^
  23. Adtralza: Pending EC decision European Medicines Agency (EMA), 23 April 2021, retrieved 23 April 2021^
  24. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 64 WHO Drug Information, 2010^
  25. Statement On A Nonproprietary Name Adopted By The USAN Council: Tralokinumab American Medical Association, retrieved 4 July 2022^