Spanish pharmaceutical company Almirall S.A. (BME:ALM) said on Monday that the European Medicines Agency has accepted its submission to extend the Marketing Authorisation Application for Ebglyss (lebrikizumab) to treat children and adolescents aged 6 months to under 18 years with moderate-to-severe atopic dermatitis.

The application is supported by data from the paediatric clinical programme, including the Phase III ADorable-1 study and the ADorable-2 long-term extension study.

Almirall said ADorable-1 met its co-primary and key secondary endpoints versus placebo, showing improvements in skin clearance, disease severity, itch and quality of life, with no new safety signals identified.

The safety profile was consistent with the established profile of lebrikizumab, which is approved in Europe for adults and adolescents aged 12 years and older.

Almirall highlighted the significant impact of atopic dermatitis in children, noting that around 60% of cases appear within the first year of life and 85% before age five.

Almirall holds rights to develop and commercialise lebrikizumab for dermatology indications in Europe, while Eli Lilly and Company (NYSE:LLY) retains rights in the United States and other regions outside Europe.