BARCELONA, Spain, July 17, 2026
Almirall S.A. has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) extension for Ebglyss® (lebrikizumab) to treat children and adolescents aged 6 months to under 18 years weighing less than 40 kg with moderate-to-severe atopic dermatitis. The regulatory submission represents a significant milestone in expanding access to IL-13-targeted biologic therapy for younger patients living with chronic inflammatory skin disease. Supported by positive results from the Phase III ADorable-1 study and the ADorable-2 long-term extension trial, the application reinforces the growing clinical evidence for lebrikizumab in pediatric atopic dermatitis. If approved, the expanded indication could provide an important new treatment option for children whose disease requires systemic therapy, helping improve disease control at an earlier stage of life while reducing the long-term burden associated with chronic eczema.
Phase III Studies Demonstrate Strong Clinical Benefit
The EMA submission is supported by data from Almirall’s comprehensive pediatric clinical development program, including the pivotal Phase III ADorable-1 trial and the ongoing ADorable-2 long-term extension study. In the ADorable-1 study, lebrikizumab successfully met both co-primary and key secondary endpoints, demonstrating statistically meaningful improvements in skin clearance, disease severity, itch reduction, and quality of life compared with placebo. The therapy also maintained a favorable safety profile, consistent with previous studies involving adults and adolescents aged 12 years and older, with no new safety signals identified during the pediatric evaluation. These findings strengthen confidence in the potential role of lebrikizumab as a long-term biologic treatment for younger patients affected by moderate-to-severe atopic dermatitis.
Early Disease Control May Improve Long-Term Outcomes
Atopic dermatitis is one of the most common chronic inflammatory skin disorders affecting children, with approximately 60% of cases developing during the first year of life and nearly 85% occurring before five years of age. Persistent disease can significantly affect sleep, physical comfort, emotional wellbeing, family life, and overall quality of life throughout childhood and adolescence. Increasing evidence suggests that early and effective disease management may reduce long-term disease burden while supporting healthier physical and psychological development. By targeting interleukin-13 (IL-13), a key driver of type 2 inflammation, Ebglyss® selectively interrupts inflammatory signaling without causing broad immunosuppression, offering a targeted approach designed to provide sustained symptom control with an established safety profile.
Advertisement
Regulatory Expansion Strengthens Pediatric Dermatology Pipeline
The EMA’s acceptance of the application marks an important regulatory step toward expanding Ebglyss® into younger pediatric populations across Europe. Almirall currently holds the European rights to develop and commercialize lebrikizumab for dermatology indications under a licensing agreement with Eli Lilly and Company, while Lilly retains commercialization rights outside Europe. The biologic is already approved in Europe for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older weighing at least 40 kilograms who are candidates for systemic therapy. If approved for children aged 6 months and older, Ebglyss could become an important addition to pediatric dermatology treatment options, helping physicians intervene earlier in disease progression and improving long-term clinical outcomes for children living with severe eczema. The submission further highlights Almirall’s commitment to advancing innovative dermatology biologics addressing significant unmet medical needs in pediatric inflammatory skin diseases.
Source: Almirall press release
