It is not currently approved in any market for adolescent use.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending extending the approval of LEO Pharma’s Adtralza (tralokinumab) 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, is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. 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,” says Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S, in a news release. “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).

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.

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.

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.