Adtralza (tralokinumab) 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 atopic dermatitis signs and symptoms.

The European Commission (EC)e xtended the marketing authorization for LEO Pharma’s  Adtralz (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

“Safety is a priority when selecting a treatment option for adolescents living with moderate-to-severe atopic dermatitis, as it can be a chronic and life-long condition,” says Dr. Andreas Wollenberg, dermatologist, allergist, and Professor in the Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Germany, and ECZTRA 6 clinical trial investigator, in a news release. “In the ECZTRA 6 trial, we found the safety and efficacy data of Adtralza to be consistent with adult trials and ongoing long-term safety studies. These findings support the use of this new biologic that specifically targets IL-13 in adolescent patients.”

The approval 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. The approved 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.2

“Moderate-to-severe atopic dermatitis significantly impacts the lives of adolescents living with the condition, who cope with the discomfort of itch, the challenges of sleep loss and mental health impacts while also navigating this formative period when they transition to adulthood,” says Korey Capozza, MPH, Founder and Executive Director, Global Parents for Eczema Research (GPER). “This group currently faces limited treatment options, and the addition of more options is a positive development for young people living with moderate-to-severe AD.”

The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.

“The European Commission’s approval of Adtralza for use in adolescent patients is a demonstration of our relentless commitment to bringing new treatment options to those living with atopic dermatitis,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “Today’s announcement enables us to address the unmet needs of a broader patient population as we look forward to working with key stakeholders across Europe to make Adtralza available to adolescent patients who need it.”

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, with 289 patients aged 12 to 17 (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.

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.

At Week 16, patients who responded to Adtralza with an IGA score of 0/1 and/or EASI change of at least 75 percent 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.