LEO Pharma A/S, a global leader in medical dermatology announced that the Committee for Medicinal Products for Human Use 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 positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorization Application for use of Adtralza, an investigational therapy in clinical development, throughout the European Union. This final decision is expected in the coming months and if authorized, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. Adtralza specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic dermatitis, which is a complex and chronic inflammatory skin condition.
“Atopic dermatitis is characterized by its unpredictability, which can be challenging for patients who often experience physical discomfort and emotional effects that may continue for decades,”said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “Today’s CHMP opinion brings LEO Pharma one step closer to the potential of providing Adtralza as a new therapeutic option for EU patients living with moderate-to-severe atopic dermatitis.”
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.
Pending the final decision from the European Commission, the marketing authorization will be valid in all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway [with the U.S. Food and Drug Administration (FDA)] and other health authorities worldwide.