Ebglyss (Lebrikizumab) Approved for Atopic Dermatitis, Offering Early Itch Relief

In a major development for those battling moderate-to-severe atopic dermatitis, the US Food and Drug Administration (FDA) approved Eli Lilly’s Ebglyss (lebrikizumab-lbkz). This treatment is specifically designed for patients 12 years and older who weigh at least 88 pounds and have not achieved sufficient control with topical therapies.

Ebglyss targets IL-13, a key cytokine linked to eczema’s inflammatory pathways, and may help alleviate the often unbearable symptoms of dry, itchy skin.

The FDA approval is based on data gathered in three pivotal Phase III clinical trials: ADvocate 1, ADvocate 2 and ADhere. Over 1,000 individuals participated in these studies, which primarily focused on patients unresponsive to topical treatments.

In the ADvocate studies, 38 percent of patients on lebrikizumab achieved clear or almost-clear skin by week 16, a marked contrast to the 12 percent in the placebo group. The trials assessed factors like redness, skin thickening and persistent itching, with many patients maintaining improvements in these factors over the course of a year. Itch relief was another significant outcome: 43 percent of patients experienced relief — compared to 12 percent on placebo — by the 16th week, and five percent reported relief as early as two weeks into the treatment.

In the ADhere trial, patients treated with the combination of Ebglyss (lebrikizumab) and topical corticosteroids achieved significantly better outcomes compared to those treated with corticosteroids alone. By week 16, 41.2 percent of patients in the combination group reached clear or almost-clear skin, versus 22.1 percent in the corticosteroid-only group. Furthermore, 69.5 percent of the combination group showed a 75 percent improvement in disease severity, compared to 42.2 percent in the corticosteroid group. The combination also provided superior itch relief, with 50.6 percent of patients reporting improvement, compared to 31.9 percent in the corticosteroid group.

The continued benefits from these studies suggest that Ebglyss could serve as a first-line biologic option for those who struggle to control their atopic dermatitis with existing therapies.

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New drug approvals are particularly important for adolescents with moderate-to-severe atopic dermatitis, a group that some studies show often experiences significant impacts on their daily lives, such as disrupted sleep and school absenteeism​. Ebglyss could offer a new treatment option that can help manage severe symptoms and improve the quality of life for patients.

While Ebglyss introduces a new pathway by targeting IL-13, several other therapies are emerging in the atopic dermatitis treatment space. Organon’s acquisition of Dermavant, including Vtama (tapinarof cream one percent), signals a push toward topical treatments, with Vtama already approved for plaque psoriasis and being investigated for use in adults and adolescents with atopic dermatitis.

Additionally, Adbry (tralokinumab-ldrm), another IL-13 inhibitor, has now introduced an autoinjector option, broadening access for adults with moderate-to-severe atopic dermatitis.

Incyte’s Opzelura (ruxolitinib cream), first approved by the FDA in 2021 for atopic dermatitis, has continued to gain attention, including through its latest commercial, which emphasized its role in relieving itch for eczema patients.

Related: Nemolizumab Approved for Adults with Prurigo Nodularis

In terms of new and ongoing studies, Pfizer, among others, currently has a few atopic dermatitis clinical trials lined up, with many actively recruiting participants. These innovations emphasize the rapidly expanding arsenal of therapies designed to tackle stubborn itch and improve skin clearance.

Ebglyss’ clinical trial side effects were mostly manageable but included eye inflammation, injection site reactions and shingles. The Phase III program for Ebglyss spanned five global studies, encompassing monotherapy (ADvocate 1 and 2), combination therapy with corticosteroids (ADhere), a long-term study in adults (ADjoin) and an open-label study (ADore) in adolescent populations. As the approval rolls out, further insights are anticipated from the ongoing ADmirable and ADapt studies, with results expected in late 2024 and early 2025.