Dupilumab

Eli Lilly has posted positive results for its IL-13 inhibitor Ebglyss that could set it up for approval in children as young as 6 months old. Eli Lilly scored $408 million in U.S. sales of eczema treatment Ebglyss in its first full year on the market in 2025. Now, with positive results from a phase 3 trial of the IL-13 inhibitor, the Indianapolis drugmaker is set up to make it available to a younger group of patients.The study, which included 363 patients ages 6 months to 18 years with moderate to severe atopic dermatitis, met its primary and key secondary endpoints by alleviating disease symptoms, while providing skin clearance and itch relief at Week 16, Lilly reported Monday. Participants received placebo or a weight-based dose of Ebglyss and were on topical steroids beginning two weeks before randomization and throughout the study.The trial achieved its primary endpoint as 63% of patients on Ebglyss achieved meaningful skin improvement compared to 22% of those on placebo, according to Lilly. The Eczema Area Severity Index (EASI) was used as a measurement tool, with 75% improvement from baseline considered “meaningful.” As a secondary measure, 39% of those on Ebglyss reached 90% improvement on the EASI index compared to 11% of the patients on placebo. When measured using the Investigator Global Assessment (IGA) index—which is a clinician rating scale of 0 (clear) to 4 (severe)—Ebglyss achieved a 44% success rate, with IGA grades at 0 or 1 (almost clear), compared to 15% of those who reached the standard on placebo.Additionally, 35% of patients on Ebglyss gained a four-point improvement in pruritus (itch) symptoms compared to 6% of those who received placebo.   Lilly said it plans to submit these data to U.S. and global regulators for a potential label update. Atopic dermatitis is more common in children than adults, affecting roughly 9.6 million kids in the U.S., with roughly one-third having a moderate to severe case of the disorder.  “Children with moderate-to-severe atopic dermatitis often endure relentless skin flares, itch and discomfort that can disrupt play, school and daily life for patients and caregivers,” Adrienne Brown, Lilly’s president of immunology, said in a release. “Ebglyss has already changed what's possible for adults and adolescents, delivering durable results that help patients flare less with the option of monthly maintenance dosing.” The FDA signed off on Ebglyss in September 2024 for those with moderate to severe atopic dermatitis. The nod covered adults and children age 12 and older who weigh at least 88 pounds. Lilly acquired the treatment when it bought out California-based Dermira for $1.1 billion.Almirall, which commercializes the treatment in Europe, reported sales of Ebglyss at 111 million euros ($125 million) in 2025. In the indication, Lilly and Almirall compete with Regeneron and Sanoifi’s IL-4 and IL-13 powerhouse Dupixent, which already is approved for those age 6 months and older, and Leo Pharma’s IL-13 Adbry. 

Eli Lilly announced positive Phase III results for Ebglyss (lebrikizumab-lbkz) in pediatric patients aged six months to 18 years with moderate-to-severe atopic dermatitis. The ADorable-1 trial met both co-primary endpoints at Week 16, generating the first Phase III dataset for a selective IL-13 inhibitor in children as young as six months, a population with limited approved systemic treatment options. ADorable-1 (NCT05559359) is a randomized, double-blind, placebo-controlled Phase III study that enrolled 363 pediatric participants with moderate-to-severe atopic dermatitis. Patients were randomized to receive placebo or weight-based doses of lebrikizumab. All participants used topical corticosteroids beginning two weeks before randomization and throughout the 16-week treatment period, though tapering was permitted once patients reached an Investigator’s Global Assessment score of 2 or less. At Week 16, 63% of lebrikizumab-treated patients achieved EASI-75, compared with 22% on placebo. For the second co-primary endpoint, 44% of lebrikizumab-treated patients achieved IGA 0 or 1 with a reduction of at least 2 points from baseline, versus 15% on placebo. Among key secondary endpoints, 39% of patients on lebrikizumab reached EASI-90 compared with 11% on placebo, and 35% of patients aged six years and older achieved a Pruritus NRS improvement of at least 4 points, versus 6% on placebo. The company did not disclose p-values or confidence intervals in its topline announcement. The safety profile was consistent with that observed in adult and adolescent studies, the company said, with no new signals identified. Upper respiratory tract infections and nasopharyngitis were the most common adverse events occurring in 5% or more of participants, with no numerical imbalance between arms. No injection site pain was reported in either group. Lilly stated it plans to submit these data to the US FDA and other global regulators to support a potential label expansion into younger pediatric populations. The ADorable program continues, with results from ADorable-2, a 52-week extension study of ADorable-1 participants, expected later this year. EBGLYSS received US FDA approval in 2024 for adults and children aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis not adequately controlled by topical prescription therapies. The drug was approved in the EU in 2023 and in Japan and Canada in 2024. Lebrikizumab is a monoclonal antibody that binds soluble IL-13 at a site overlapping with the IL-4Rα binding region on the IL-13Rα1/IL-4Rα receptor complex, preventing receptor assembly and downstream signaling. IL-13 is considered a central driver of type 2 inflammation in atopic dermatitis, contributing to skin barrier dysfunction, epidermal thickening, pruritus, and susceptibility to infection. By selectively neutralizing IL-13 without blocking IL-4, lebrikizumab differs mechanistically from dupilumab, which targets the shared IL-4Rα subunit used by both cytokines. Atopic dermatitis affects an estimated 9.6 million children in the United States, according to the company, with roughly one-third experiencing moderate-to-severe disease. Treatment options for younger children remain more limited than those available to adults and adolescents. Topical corticosteroids and calcineurin inhibitors remain first-line therapy, while systemic options have expanded in recent years for older patients. The ADorable-1 data, if they support regulatory approval, could extend the labeled use of lebrikizumab to patients as young as six months. Key competitors include: Sanofi and Regeneron’s dupilumab, an IL-4Rα antagonist that received US FDA approval for children aged six months to five years with moderate-to-severe atopic dermatitis in 2022, making it the first biologic approved for this age group. LEO Pharma’s tralokinumab, another IL-13 inhibitor approved for adults, with ongoing Phase 3 pediatric studies. AbbVie’s upadacitinib, an oral JAK1 inhibitor approved for adults and adolescents with moderate-to-severe atopic dermatitis, with pediatric studies underway. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website