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CHMP recommends approval of Adtralza in atopic dermatitis.- LEO Pharma

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Last updated:24th Sep 2021
Published:26th Apr 2021
LEO Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.The CHMP opinion is based primarily on data from three pivotal randomized, double-blind, placebo-controlled trials (ECZTRA 1, 2 and ECZTRA 3), which evaluated the safety and efficacy of Adtralza as monotherapy and with concomitant topical corticosteroids (TCS) in more than 1,900 adult patients with moderate-to-severe atopic dermatitis. 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, including the extent and severity of skin lesions, pruritus (itch), sleep and health-related quality of life measures, were measured by changes in the following scores: EASI-90, SCORing Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS), Eczema-Related Sleep NRS and Dermatology Life Quality Index (DLQI). The trials demonstrated that Adtralza met the primary and secondary efficacy endpoints and was generally well tolerated.
Condition: Atopic Dermatitis (Eczema)
Type: drug

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