EU approves Adtralza for moderate-to-severe atopic dermatitis
LEO Pharma announced that the European Commission (EC) has extended the marketing authorization for Adtralza (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy
The approval is based on data from the Phase III 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.
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.
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