Almirall Announces EMA Acceptance for Filing of Paediatric Registration of Ebglyss (Lebrikizumab) in Atopic Dermatitis in Children 6 Months and Older

By:

Add as a preferred source on Google

Almirall, S.A. (ALM), a global biopharmaceutical company focused on medical dermatology, today announced that the European Medicines Agency (EMA) has accepted the submission of the extension of the Marketing Authorisation Application (MAA) of Ebglyss® (lebrikizumab) for the treatment of children and adolescents aged 6 months to <18 years and weighing below 40 kg with moderate-to-severe atopic dermatitis.

The application is supported by interim results from the paediatric clinical program 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 life3, with most cases appearing by the first year of life (60%) or before 5 years of age (85%)4. Given its potential to have a lasting impact on patients and their families, effective disease control is increasingly recognized as an important opportunity to reduce long-term disease burden and support healthier life trajectories5.

“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,” said Dr Karl Ziegelbauer, Chief Scientific Officer at Almirall.

“Atopic dermatitis often begins early in life and can have a lasting impact on patients and their families. At Almirall, we are committed to addressing patients’ needs holistically, and early and effective disease control can help reduce the long-term burden of disease and enable healthier life trajectories for children living with atopic dermatitis,” said Dr Volker Koscielny, Chief Medical Officer at Almirall.

Almirall was licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe, while Eli Lilly and Company retains rights for development and commercialization in the United States and the rest of the world outside Europe.

About Lebrikizumab

Lebrikizumab (LEB) is a monoclonal antibody that selectively targets the cytokine IL-13 with high affinity, blocking its downstream signaling6,7,8,9,10, while avoiding broader immunosuppression11,12 and preserving IL-13 physiological clearance13. Lebrikizumab is approved in Europe, under the brand name Ebglyss®, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy14.

About Almirall

Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.

For more information, please visit https://www.almirall.com/

Legal warning

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are “forward-looking statements”. These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

1 Silverberg JI. Comorbidities and the impact of atopic dermatitis. Ann Allergy Asthma Immunol. 2019;123(2):144‑151. doi:10.1016/j.anai.2019.04.020

2 Luger T. et al. The long-term impact of childhood and adolescent atopic dermatitis on physical and psychosocial wellbeing: Scars of Life project. Clin. Exp. Dermatol. 2026, 00, 1–3 https://doi.org/10.1093/ced/llag173

3 Silverberg JI. Comorbidities and the impact of atopic dermatitis. Ann Allergy Asthma Immunol. 2019;123(2):144‑151. doi:10.1016/j.anai.2019.04.020

4 Weidinger S, Simpson EL, Silverberg JI, et al. Burden of atopic dermatitis in paediatric patients: an international cross‑sectional study. Br J Dermatol. 2024;190(6):846‑857. doi:10.1093/bjd/ljad449.

5 Luger T. et al. The long-term impact of childhood and adolescent atopic dermatitis on physical and psychosocial wellbeing: Scars of Life project. Clin. Exp. Dermatol. 2026, 00, 1–3 https://doi.org/10.1093/ced/llag173

6 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.

7 Okragly AJ, Ryuzoji A, Wulur I, Daniels M, Van Horn RD, Patel CN, et al. Binding, neutralization and internalization of the interleukin‑13 antibody, lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535‑1547.

8 Ultsch M, Bevers J, Nakamura G, et al. Structural basis of signaling blockade by anti‑IL‑13 antibody lebrikizumab. J Mol Biol. 2013;425(8):1330‑1339.

9 Tsuji G, Yamamura K, Kawamura K, Kido‑Nakahara M, Ito T, Nakahara T. Novel therapeutic targets for the treatment of atopic dermatitis. Biomedicines. 2023;11:1303.

10 Furue M, Ulzii D, Nakahara T, Tsuji G, Furue K, Hashimoto‑Hachiya A, et al. Implications of IL‑13Rα2 in atopic skin inflammation. Allergol Int. 2020;69:412‑416.

11 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.

12 Gonçalves F, Freitas E, Torres T. Selective IL‑13 inhibitors for the treatment of atopic dermatitis. Drugs Context. 2021;10:2021‑1‑7. doi:10.7573/dic.2021‑1‑7.

13 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.

14 European Medicines Agency (EMA). Ebglyss: EPAR—Product Information. Accessed February 7, 2026. https://www.ema.europa.eu/en/documents/product-information/ebglyss-epar-product-information_en.pdf

Contact

Corporate Communications:
[email protected]
Phone: (+34) 659 614 173

Investor Relations:
[email protected]
Phone: (+34) 93 291 30 87

Company Logo
Company Logo