LEO Pharma's Adtralza (tralokinumab) has received approval from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) to extend its use for the treatment of moderate-to-severe atopic dermatitis (AD) in adolescent patients aged 12 to 17 years who are candidates for systemic therapy. This approval addresses a critical need, as approximately 6% of adolescents in this age group in the UK suffer from atopic dermatitis.
The EC and MHRA approvals are based on data from the Phase 3 ECZTRA 6 trial, a randomized, double-blind, placebo-controlled study involving 301 patients aged 12 to 17. The trial evaluated the efficacy, safety, and tolerability of tralokinumab (150mg or 300mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD. Tralokinumab, a high-affinity human monoclonal antibody, specifically targets and neutralizes interleukin (IL)-13 cytokine, a key driver in the immune and inflammatory processes underlying AD.
The recommended dose for adolescent patients mirrors that of adults: an initial dose of 600mg followed by 300mg administered every other week. Tralokinumab is already approved for treating adults with moderate-to-severe atopic dermatitis in several regions, including the EU, UK, Canada, United Arab Emirates, and Switzerland, and in the US under the brand name Adbry.
Long-Term Efficacy of Adbry
In addition to the adolescent approval, LEO Pharma has announced long-term safety and efficacy data for Adbry (tralokinumab-ldrm), demonstrating its ability to maintain clear or almost clear skin for up to six years. Data from the Phase III ECZTEND study showed that 92.9% of patients on long-term maintenance treatment with Adbry experienced at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at week 248. Furthermore, 66.7% of patients achieved clear or almost clear skin, as assessed by the Investigator’s Global Assessment (IGA) scale. No new safety signals were identified during the study.
Mechanism of Action and Availability
Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes associated with atopic dermatitis symptoms. The drug was initially approved by the FDA in 2021 for adults with moderate-to-severe atopic dermatitis, with the label expanded in 2023 to include adolescents aged 12 and older. In June 2024, the FDA approved a single-dose autoinjector for Adbry, offering a more convenient administration option for patients.
Sarah Kleinpeter, Vice President and General Manager of UK & Ireland at LEO Pharma, stated, "We are pleased that adolescents between 12-17 years of age living with atopic dermatitis will now have more treatment options available to them. LEO Pharma is committed to working with regulatory authorities to make tralokinumab available to all patients who need it."
Dr. James Halpern, Consultant Dermatologist for Dermatology at Walshall Healthcare NHS Trust, added, "(AD) is an underestimated condition that has a significant impact on a young person’s quality of life. The extended approval of tralokinumab for the treatment of adolescents with atopic dermatitis is an important development, giving dermatologists more treatment options for this group of patients."
