EMA accepts extension

The European Medicines Agency (EMA) has accepted Almirall's submission of the extension of the Marketing Authorisation Application (MAA) for Ebglyss (lebrikizumab) in children and adolescents with moderate‑to‑severe atopic dermatitis. The application is supported by data from the paediatric clinical programme, including interim results from the pivotal Phase III ADorable‑1 study and the long‑term extension (LTE) study ADorable‑2. Lebrikizumab demonstrated meaningful improvements in skin clearance, disease severity, itch, and quality of life compared to placebo in children aged 6 months to <18 years with moderate‑to‑severe atopic dermatitis. The safety profile was consistent with the established safety profile of lebrikizumab approved for adults and adolescents ≥12 years old.