The European Medicines Agency (EMA) has accepted Almirall’s application to extend the use of Ebglyss (lebrikizumab) to children and adolescents aged six months to under 18 years, weighing less than 40 kg, with moderate-to-severe atopic dermatitis.

The submission is supported by data from Almirall’s paediatric clinical development programme, including the Phase 3 ADorable-1 trial and the ongoing ADorable-2 long-term extension study.

If approved, the expanded indication would make the IL-13 inhibitor available to younger patients living with moderate-to-severe atopic dermatitis who require systemic treatment.

Atopic dermatitis is one of the most common inflammatory skin diseases in children, with around 60% of cases developing during the first year of life and approximately 85% occurring before the age of five. Early disease control is considered important in helping to reduce the long-term burden of the condition for both patients and their families.

The application includes interim data from the ADorable-1 study, which evaluated the efficacy and safety of lebrikizumab in children and adolescents aged six months to under 18 years with moderate-to-severe atopic dermatitis. According to Almirall, the study met its co-primary and key secondary endpoints compared with placebo.

Patients treated with lebrikizumab showed improvements in skin clearance, disease severity, itch and quality of life. The company said the treatment’s safety profile was consistent with that previously observed in adult and adolescent patients, with no new safety signals identified.

Karl Ziegelbauer, chief scientific officer at Almirall, said: “The acceptance of this application by the EMA marks an important step towards potentially expanding access to lebrikizumab for children and adolescents living with moderate-to-severe atopic dermatitis. We are encouraged by the clinical evidence supporting this submission and its potential to address a significant unmet need for younger patients and their families.”

Lebrikizumab is a monoclonal antibody that selectively targets the cytokine IL-13, a key driver of inflammation associated with atopic dermatitis.

The medicine is currently approved in Europe under the brand name Ebglyss for adults and adolescents aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy.

Almirall holds the rights to develop and commercialise lebrikizumab for dermatology indications in Europe, while Eli Lilly and Company retains development and commercialisation rights in the United States and other markets outside Europe.

The EMA’s acceptance of the application marks the start of its regulatory review. If approved, the decision would expand access to lebrikizumab to younger children with moderate-to-severe atopic dermatitis across Europe.