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.