20 October 2022 - - The European Commission has extended the marketing authorization for Adtralza (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, Danish medical dermatology specialist LEO Pharma A/S said.

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

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

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% 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.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.

Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.

Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.

Adtralza (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin -13 cytokine7, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.

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).

Adtralza is approved for the treatment of adults and adolescents with moderate-to-severe AD in the European Union and approved for adults with moderate-to-severe AD in the United States, Great Britain, Canada, the United Arab Emirates, and Switzerland.

Adtralza is marketed in the United States under the tradename AdbryTM (tralokinumab-ldrm). Applications to extend the indication of Adtralza/Adbry to adolescents are currently under review with several agencies, including the US Food and Drug Administration.

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 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 9,957m.