Almirall’s submission to extend its Marketing Authorisation Application (MAA) for Ebglyss (lebrikizumab) to treat moderate-to-severe atopic dermatitis in children and adolescents aged six months to <18 years has been accepted by the European Medicines Agency (EMA).
The application is supported by interim results from the paediatric clinical programme for lebrikizumab, including the pivotal study ADorable-1, evaluating efficacy and safety in children and adolescents aged 6 months to <18 years with moderate-to-severe atopic dermatitis, and the ADorable-2 long-term extension (LTE) study evaluating safety and efficacy during maintenance phase.
In ADorable-1, lebrikizumab met both co-primary and key secondary endpoints compared to placebo, demonstrating meaningful improvements in skin clearance, disease severity, itch and quality of life.
The safety profile was consistent with the established safety profile of lebrikizumab approved in Europe for adult and adolescent patients 12 years and older, with no new safety signals observed.
Atopic dermatitis is more prevalent in childhood than adulthood and typically begins early in life, with most cases appearing by the first year of life (60%) or before five years of age (85%). Given its potential to have a lasting impact on patients and their families, effective disease control is increasingly recognised as an important opportunity to reduce long-term disease burden and support healthier life trajectories.
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.”
Volker Koscielny, Chief Medical Officer at Almirall, added: “Atopic dermatitis often begins early in life and can have a lasting impact on patients and their families. Effective disease control can help reduce the long-term burden of disease and enable healthier life trajectories for children living with atopic dermatitis.”
Almirall is a global biopharmaceutical company focused on medical dermatology.