LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis
16.9.2022 21:23:00 EEST | Business Wire | Press release
LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending to extend the approval of Adtralza® (tralokinumab) in the European Union (EU) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The recommended dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients.
Adtralza, a high-affinity human monoclonal antibody,1 is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland.2 It also is approved for adults in the United States under the tradename Adbry™. It is not currently approved in any market for adolescent use.
“Today’s CHMP opinion underscores our confidence in the safety profile and effectiveness of Adtralza as we seek to obtain regulatory approval to expand its indication for use in an adolescent patient population,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis. Through our clinical efforts, we have worked to ensure there is sufficient data to support bringing a new biologic option to market for these patients.”
The CHMP opinion is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD who were candidates for systemic therapy. Primary endpoints were the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).3,4
Secondary endpoints were measured by extent and severity of atopic dermatitis (SCORAD), at least a 4-point improvement in adolescent weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) score, and Children’s Dermatology Life Quality Index (CDLQI) score.3,4
The CHMP’s positive opinion will be reviewed by the European Commission (EC) and pending the final decision, the marketing authorization will be valid in all EU Member States, Iceland, Norway, and Liechtenstein. An additional regulatory filing is underway with the U.S. Food and Drug Administration (FDA).
About the ECZTRA 6 Trial
ECZTRA 6 (ECZema TRAlokinumab trial No. 6) is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, including a total of 301 patients (aged 12 to 17), with 289 (195 Adtralza patients and 94 placebo patients) in the full analysis set, evaluating the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.3,4
Following a washout period, patients were randomized to subcutaneous Adtralza 150 mg or 300 mg Q2W, or placebo for an initial 16 weeks. Adtralza dosing started with a 300 mg or 600 mg loading dose on day 0 for those receiving Adtralza 150 mg or 300 mg Q2W, respectively.3
At Week 16, patients who responded to Adtralza with an IGA score of 0/1 and/or EASI change of at least 75% from baseline, without use of rescue treatment, were re-randomized to Adtralza Q2W or Q4W for an additional 36 weeks. Patients not achieving primary endpoints at week 16, those receiving rescue treatment from week 2 to week 16, and those meeting other specific criteria were transferred to open-label treatment of Adtralza 300 mg Q2W plus optional mild-to-moderate strength topical corticosteroids.3
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.6 Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.7
About Adtralza® (tralokinumab)
Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine1, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.2,7 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).1,7
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.
References
- Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208–19.
- Adtralza® (tralokinumab) EU Product Information. LEO Pharma; June 2021.
- Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. Fall Clinical. Oct. 21-24, 2021. Poster Presentation.
- ClinicalTrialsRegister.eu. Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: 2017-005143-33.
- Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
- Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
- Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
MAT-58697 September 2022
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220916005458/en/
Contact information
David Patti
LEO Pharma, Global Product Communications
+1 973.796.7706
DAPAI@leo-pharma.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 16:00:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Sentinel satellites to create detailed embeddings - compressed AI representations - of every 10-meter square of Earth's surface. TESSERA represents the most accurat
Omilia Appoints Ryan Kam as Chief Marketing Officer to Lead Global Brand and Growth Strategy22.7.2026 15:00:00 EEST | Press release
Omilia, a global leader in Self-Learning Agentic CX, today announced the appointment of Ryan Kam as Chief Marketing Officer (CMO). Ryan will be responsible for Omilia's global brand, demand generation, and marketing strategy as the company scales its go-to-market presence across enterprise markets. In his new role, Kam will own Omilia's global marketing function, spanning brand strategy, demand generation, product marketing, analyst relations and communications. He joins at a moment of significant commercial momentum: Omilia has seen accelerating enterprise demand across all industries and is investing in a marketing engine built to match the pace of its growth. Ryan Kam brings more than 20 years of marketing leadership across some of the most recognized names in enterprise technology. Most recently, he served as CMO at Egnyte, a leader in cloud content security and governance. Prior to that, Kam held the CMO role at LogicMonitor, where he drove growth for one of the leading infrastruc
Echodyne Announces ATAK Integration for MESA® Radar Platform22.7.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, today announced the availability of an Android Team Awareness Kit (ATAK) plugin for its MESA® radar platform. The integration enables users to configure, control, and visualize data from Echodyne radars within the ATAK environment, supporting military, public safety, and security operations that rely on TAK for shared situational awareness. The plugin extends radar management and visualization capabilities to ATAK users, allowing high-fidelity radar data and system controls to be accessed through a familiar operational interface. By integrating radar data into existing TAK workflows, organizations can streamline deployment, reduce operator workload, and improve access to real-time situational awareness. TAK is a government-developed geospatial platform used across U.S. military, federal, state, and local government organizations, as well as by U.S. partner nations. According to the U.S. Army TAK Product Center, the TAK ecosystem supports 15 Departm
OneSpan Introduces DigipassONE, Bringing a Unified Platform Approach to Authentication Modernization22.7.2026 15:00:00 EEST | Press release
Organizations are under increasing pressure to modernize authentication while supporting existing infrastructure, meeting evolving regulatory requirements, deploying emerging technologies, and reducing operational complexity. For financial institutions in particular, authentication modernization must balance security, compliance, and operational efficiency while meeting the evolving expectations and preferences of their customers. Yet the journey to modern authentication is rarely a single technology transition. Organizations must continue supporting multiple authentication methods while gradually adopting new technologies, making it essential to modernize without disrupting existing environments, user experiences, or business operations. To help organizations navigate this transition, OneSpan Inc. (NASDAQ: OSPN) today announced DigipassONE™, its unified platform for authentication, transaction security, in-app protection, analytics and digital credential innovation. DigipassONE introd
StructureCraft Scales Data-Driven Design on NetApp22.7.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that StructureCraft, an award-winning global structural engineering and construction firm known for complex timber and hybrid builds, is now using NetApp to modernize and create an AI-ready data infrastructure. The new infrastructure enables the company’s employees to collaborate globally, store and manage large-scale design workloads, and take advantage of AI-driven tools on a scalable, centralized platform. StructureCraft specializes in innovative timber engineering, structural design, and sustainable building solutions for large-scale architectural projects worldwide. Its globally distributed team delivers complex projects across North America, Europe, and Asia, guided by a core purpose to engineer and build beautiful, efficient structures. The StructureCraft team regularly takes on complex projects such as designing and constructing of the Barbados National Performing Arts Pavilion, a ground-breaki
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom