The CHMP's recommendations are based on data from a phase 3 ECZTRA 6 trial in adolescents with moderate-to-severe AD cases.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends extending the approval of Adtralza (tralokinumab) to include adolescents aged 12 to 17 suffering from moderate-to-severe atopic dermatitis (AD) and who are candidates for systemic therapy.1
Adtralza is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying AD signs and symptoms.2
The CHMP recommendation is based on data from a Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of the drug (150 mg or 300 mg) monotherapy compared to placebo in adolescents with AD who were candidates for systemic therapy. Primary endpoints were the investigator global assessment score of clear or almost clear skin and at least a 75% improvement in the eczema area. 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.
This is an important step forward for Adtralza manufacturer, Denmark-based LEO Pharma; the company said it would be able to help serve unmet needs for a broader portion of the AD community; including many patients who live with the physical, psychosocial, and emotional toll of AD who have limited treatment potions.
AD is the most common inflammatory skin condition in pediatric patients, affecting 10% to 30% of patients worldwide.3 It is the result of skin barrier dysfunction and immune deregulation, leading to chronic inflammation. Some patients see a resolution of AD during childhood but then a reappearance of symptoms during the adolescent years.
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.
1. LEO Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the teatment of adolescents with moderate-to-severe atopic dermatitis. Leo Pharma. https://www.leo-pharma.com/media-center/news/leo-pharma-receives-positive-chmp-opinion-of-adtralza-tralokinumabPublished September 16, 2022. Accessed September 20, 2022 .
2. Adtralza® (tralokinumab) EU Prescribing information. LEO Pharma; June 2021.Accessed September 20, 2022.https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_en.pdf
3.Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246. doi:10.1111/j.1600-065X.2011.01027.x