Eli Lilly's New Eczema Drug Competes with Sanofi, LEO Pharma

Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. Despite numerous available treatments, many patients find existing therapies insufficient. Recently, the FDA approved a new biologic treatment from Eli Lilly, aimed at providing a less burdensome dosing schedule for patients. This new drug, lebrikizumab, will be marketed under the name Ebglyss.

The FDA's decision permits Ebglyss for use in adults and children aged 12 and older with moderate-to-severe atopic dermatitis that remains uncontrolled by topical prescription medications. Ebglyss, which has already gained approval in Europe and Japan, aims to provide a new alternative for managing this challenging condition.

Atopic dermatitis affects over 16 million adults in the United States, with around 6.6 million experiencing moderate-to-severe symptoms according to the National Eczema Association. Traditional treatments often include topical steroids that help to reduce inflammation, but these do not always provide adequate symptom control. Ebglyss introduces a novel approach by targeting IL-13, a signaling protein linked to the inflammation seen in atopic dermatitis. This injectable medication was initially developed by Dermira, a skin disease biotech company acquired by Eli Lilly for $1.1 billion in 2020.

Prior to Ebglyss, existing drugs targeting IL-13 for atopic dermatitis treatment have been available. Notably, Sanofi and Regeneron Pharmaceuticals’ drug Dupixent, which targets IL-13 and IL-14, has been a successful biologic treatment for atopic dermatitis since its FDA approval in 2017. Another drug, Adbry from LEO Pharma, specifically targets IL-13 and was approved by the FDA in 2021. Both Dupixent and Adbry are administered bi-weekly after initial dosing.

Ebglyss distinguishes itself by offering once-monthly maintenance dosing, potentially making it more convenient for patients. The FDA's approval of Ebglyss was based on data from two Phase 3 clinical trials. These studies revealed that 38% of participants who received Ebglyss achieved clear or nearly clear skin at 16 weeks, compared to 12% in the placebo group. Additionally, 77% of those who saw clear or almost-clear skin at week 16 maintained these results after one year with monthly dosing.

The studies also demonstrated significant itch relief, with 43% of Ebglyss-treated participants experiencing reduced itchiness at 16 weeks versus 12% in the placebo group. Of those who experienced itch relief at week 16, 85% continued to feel relief one year later with monthly maintenance dosing. Common side effects observed in the studies included eye and eyelid inflammation, injection site reactions, and shingles.

Jonathan Silverberg, a professor of dermatology at George Washington University School of Medicine and Health Sciences and the lead author of the Ebglyss clinical trial results, emphasized the importance of this new treatment option. He highlighted that many patients still struggle with moderate-to-severe atopic dermatitis despite existing therapies, making the FDA approval of Ebglyss a significant advancement.

The approval of Ebglyss in the United States follows its earlier acceptance in Europe and Japan. The European Commission approved the drug last November, and Japanese regulators followed suit earlier this year. Lilly, which retains global rights to Ebglyss (except in Europe), expects further regulatory decisions in additional markets later this year. The company announced that Ebglyss will be available in the U.S. in the coming weeks.