EMA Accepts Almirall's Application for Pediatric Use of Ebglyss in Atopic Dermatitis
Almirall, a global biopharmaceutical company, has announced that the European Medicines Agency (EMA) has accepted its submission for the extension of the Marketing Authorisation Application (MAA) for Ebglyss (lebrikizumab). This application pertains to the treatment of children and adolescents aged 6 months to under 18 years with moderate-to-severe atopic dermatitis. The submission is supported by data from the pediatric clinical program, including the pivotal Phase III ADorable-1 study and the ADorable-2 long-term extension study. These studies demonstrated significant improvements in skin clearance, disease severity, itch, and quality of life for patients, with a safety profile consistent with previous findings. Atopic dermatitis is a common condition in children, often beginning early in life, and effective management is crucial to reducing long-term disease burden. 
