The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

  • LOG IN
  • BECOME A MEMBER
  • About
    • Mission & Activities
    • Board of Directors
    • Our Staff & Volunteers
    • The Antibody Society’s Standing Committees
      • AIRR Community Committee
      • Communication & Membership Committee
      • Initiatives Committee
      • Meetings Committee
    • Sponsors & Partners
  • Society meetings
    • Biopharmaceutical Informatics Symposium
    • Harnessing Cytokines for Cancer Immunotherapy Symposium
    • Emerging Cancer Therapies Leveraging Gamma-Delta Effector T cells Symposium
    • Emerging Immunotherapeutics for Ovarian Cancer Symposium
    • AIRR Community Meetings
    • Antibody Engineering & Therapeutics (US) 2022
      • 2020 Antibody Engineering & Therapeutics
      • 2019 Antibody Engineering & Therapeutics
      • 2018 Antibody Engineering & Therapeutics
      • What is INN a Name?
        • INN issue updates
    • Antibody Engineering & Therapeutics Europe 2022
    • FOCIS Symposia
  • AIRR Community
    • AIRR News
    • AIRR Publications
    • AIRR Meetings
      • AIRR Community Meeting VI: “Exploring New Frontiers”
      • AIRR Community Meeting V: “Zooming in to the AIRR Community”
      • AIRR Community Meeting V Pre-Meetings
        • AIRR-seq in the Pandemic
        • AIRR-seq Biological Standards and Workflows
      • AIRR Community Special Event: “Response to COVID-19”
      • AIRR Community Meeting IV: “Bridging the Gaps”
      • AIRR Community Meeting III
        • Day 1
        • Day 2
        • Day 3
        • Day 4
      • AIRR Community Meeting II
      • AIRR Community Meeting I
    • AIRR Community Working Groups
      • Biological Resources Working Group
      • Common Repository Working Group
      • Diagnostics Working Group
      • Germline Database Working Group
      • Legal and Ethics Working Group
      • Software Working Group
      • Standards Working Group
    • AIRR Community Sub-committees
      • Communications Sub-committee
      • Executive Sub-committee
      • Inferred Allele Review Committee
      • Meetings Sub-committee
    • AIRR Data Commons
    • AIRR Community Calendar
    • AIRR Community Webinar Series
    • On AIRR – An AIRR Community Podcast
    • AIRR Community Resources
    • AIRR Community Service Prize 2022
  • Members only
    • Login
    • Note to members
    • James S. Huston Antibody Science Talent Award
      • 2020 James S. Huston Antibody Science Talent Award Recipient
      • JSH Award Criteria
    • Research Competitions
      • Research Competition Winners
    • Science Writing Competition
      • Science Writing Competition Winners
    • Member discount codes
    • Antibodies in early-stage studies
    • Presentations
  • Upcoming meetings
  • Web Resources
    • Society Publications
    • Antibody News
    • Antibody therapeutics approved or in regulatory review in the EU or US
      • Antibody therapeutics product data
    • Antibodies in late-stage clinical studies
    • Research Resources
    • Education Resources
  • Career Center
    • Career Shorts
  • Learning Center
    • Upcoming Webinars
    • Snakebite antivenoms: Global challenges and progress toward recombinant antibody therapeutics
    • Adaptive Immune Receptor Repertoires
    • Antibody Discovery & Development
    • Commercializing Antibody Therapeutics
    • Antibodies to Watch
    • Antibody Validation
  • COVID-19
    • Guide to “Coronavirus in the Crosshairs”
    • COVID-19 Biologics Tracker
    • Meeting Report: The Diagnostic Landscape for COVID-19
You are here: Home / Antibody therapeutic / Tralokinumab granted first approval in the European Union

Tralokinumab granted first approval in the European Union

June 23, 2021 by Janice Reichert

The European Commission has approved Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.

Tralokinumab is a human IgG4l antibody targeting IL-13, a pleiotropic T helper type 2 cytokine associated with atopic dermatitis and other inflammatory disorders. The antibody interferes with IL-13-mediated signaling by blocking its interactions with both IL-13 receptor α1 and IL-13 receptor α2. Originally identified by Cambridge Antibody Technology and developed by MedImmune as CAT-354, AstraZeneca sold the rights to tralokinumab in dermatology indications to LEO Pharma in 2016.

The marketing applications are supported by data from three Phase 3 studies, ECZTRA 1 (NCT03131648), 2 (NCT03160885), and ECZTRA 3 (NCT03363854). The randomized, double-blind, placebo-controlled, multinational, 52-week ECZTRA 1 and ECZTRA 2 trials evaluated the safety and efficacy of tralokinumab (300 mg SC) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy. ECZTRA 3 was a double-blind, randomized, placebo-controlled, multinational 32-week study of 380 patients that evaluated the safety and efficacy of tralokinumab (300 mg SC) in combination with topical corticosteroid in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.

The results of the three Phase 3 studies were recently published in the British Journal of Dermatology. [1] The primary outcome measures for the studies included an Investigator’s Global Assessment (IGA) of 0 or 1 and 75% improvement in Eczema Area and Severity Index (EASI 75) at Week 16. At this time point in the ECZTRA 1 and ECZTRA 2 studies, 15.8% and 22.2% of patients who received tralokinumab achieved an IGA score of 0/1 vs. 7.1% and 10.9% of patients who received placebo, respectively. More patients who received tralokinumab also achieved EASI 75 compared to those who received placebo (25.0% vs. 12.7% and 33.2% vs. 11.4% in ECZTRA 1 and ECZTRA 2, respectively). In the ECZTRA 3 study, which included use of topical corticosteroid, 38.9% patients who received tralokinumab achieved IGA 0/1 vs. 26.2% of those who received placebo. EASI 75 was achieved in 56.0% patients who received tralokinumab vs. 35.7% of those who received placebo. [2]

1. Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2020. doi: 10.1111/bjd.19574.

2. Silverberg JI, Toth D, Bieber T, Alexis AF, Elewski BE, Pink AE, Hijnen D, Jensen TN, Bang B, Olsen CK, Kurbasic A, Weidinger S. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2020. doi: 10.1111/bjd.19573.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Filed Under: Antibody therapeutic Tagged With: antibody therapeutics, approved antibodies, IL-13, tralokinumab

Share this post

  • LinkedIn

mabs

mabs

The Official Journal of The Antibody Society

Career Center

Our Career Center is a premier resource to connect highly qualified talent with matching career opportunities. Visit for details on over 800 jobs!

AIRR Community

AIRR Community

The Adaptive Immune Receptor Repertoire Community is a research-driven group organizing around the use of high-throughput sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

Recent Posts

  • The Society has selected mAbs as its Official Journal! July 29, 2022
  • Congratulations to our 2022 Antibody Research Competition winners! July 26, 2022
  • Register for our upcoming webinar on BLI and its use in anti-snake venom antibody discovery July 19, 2022

Archives

Follow us online

  • Email
  • LinkedIn
  • Twitter
  • YouTube
  • Home
  • Privacy & Terms of Use
  • About
  • Board of Directors
  • Advisors
  • Sponsors & Partners
  • Mission & Activities
  • Join the Society
  • Membership Levels
  • Members only
  • Login
  • Antibody therapeutics approved or in regulatory review in the EU or US
  • Meeting reports
  • Presentations
  • Contact

©2015 - scicomvisuals