Therapy is for the treatment of adolescents with moderate-to-severe atopic dermatitis.
LEO Pharma has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending to extend the approval of Adtralza in the European Union (EU).
The therapy – also known as tralokinumab – involves 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 Britain, the EU, Canada, the United Arab Emirates and Switzerland. It also is approved for adults in the US under the trade name AdbryTM.
The CHMP opinion is based on data from the phase 3 ECZTRA trial, which evaluated the efficacy and safety of Adtralza monotherapy compared to a placebo. The primary endpoints were the investigator’s global assessment score of clear or almost clear skin and at least a 75% improvement in the eczema area.
“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,” reflected Christophe Bourdon, chief executive officer at LEO Pharma.
“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,” he added.
The CHMP’s positive opinion will be reviewed by the European Commission (EC) and pending the final decision, marketing authorisation will be valid in all EU member states, Iceland, Norway and Liechtenstein. An additional regulatory filing is underway with the US Food and Drug Administration.
Atopic dermatitis is a chronic, inflammatory skin disease characterised by intense itch and eczematous lesions. Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.
