Lilly's Immunology Unit Gains FDA Approval for Eczema Drug Ebglyss

Eli Lilly has received its third FDA approval in the field of immunology with the green light for the IL-13 inhibitor Ebglyss, aimed at treating atopic dermatitis (AD). The approval covers both adults and adolescents aged 12 to 18 who weigh at least 88 pounds and have moderate-to-severe forms of AD that do not respond adequately to prescription topical treatments. Known as lebrikizumab, Ebglyss is set to be launched in the U.S. in the coming weeks, though its pricing has yet to be disclosed.

This FDA nod marks a significant milestone for Eli Lilly, which has been expanding its immunology portfolio. Previously, the company gained approval for Olumiant, a JAK inhibitor, as the first systemic treatment for alopecia areata in 2022. Additionally, in October of the previous year, it received approval for Omvoh, an IL-23 inhibitor for ulcerative colitis. This consistent expansion aligns with the company's long-term commitment to the immunology sector, as highlighted by Patrik Jonsson, the former chief of the immunology unit.

Eli Lilly acquired lebrikizumab through its $1.1 billion acquisition of Dermira, a California-based company, in 2020. The approval of Ebglyss had faced a delay, as the FDA initially rejected it in October due to concerns stemming from an inspection of a third-party manufacturer. However, these concerns did not relate to the clinical data or safety of lebrikizumab. Earlier this year, both Japan and Canada approved the drug, and it received approval last year in Europe, where Almirall has the rights for its dermatological applications.

The introduction of Ebglyss provides a new option for patients who struggle to control moderate-to-severe atopic dermatitis with existing therapies. According to Jonathan Silverberg, a professor of dermatology at George Washington University School of Medicine and Health Sciences, many patients experience poor long-term disease control and severe itching, which can significantly impact their quality of life.

Ebglyss is administered through a 250 mg injection following an introductory regimen of injections two weeks apart until an adequate clinical response is achieved. Afterward, it is dosed monthly and can be used in conjunction with topical corticosteroids. The approval is supported by three clinical trials involving over 1,000 patients. In the ADvocate 1 and 2 studies, 38% of patients treated with Ebglyss achieved clear or almost-clear skin after 16 weeks, compared to 12% of those on placebo. Among those who reached this standard, 77% maintained their results with continued dosing for a year. Additionally, 48% of those who switched to a placebo at Week 16 retained their results for a year.

Eli Lilly aims to challenge the current market leader, Dupixent, a treatment for AD developed by Regeneron and Sanofi. Dupixent, which targets IL-4 and IL-13, has been dominant in this therapeutic area. Another competitor in the market is Leo Pharma's Adbry, an IL-13 inhibitor launched in 2022.

The approval of Ebglyss expands Eli Lilly's footprint in the immunology landscape, providing a new treatment option for patients with atopic dermatitis and positioning the company to compete against established therapies in the market.