FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis, Eli Lilly Announces

The US Food and Drug Administration (FDA) has granted approval to Eli Lilly for its IL-13 inhibitor, Ebglyss (lebrikizumab-lbkz), designed to treat moderate-to-severe atopic dermatitis (AD) in patients aged 12 and older, weighing at least 40kg. This approval targets individuals whose AD symptoms are not adequately managed with topical prescription therapies.

Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin condition characterized by itchiness, dryness, and skin cracking. The prevalence of AD in the US adult population is approximately 7.3%, with around 40% of these individuals experiencing moderate to severe symptoms.

Ebglyss functions by addressing the inflammation caused by eczema throughout the body. This medication can be administered with or without topical corticosteroids and involves a single monthly maintenance injection after an initial treatment period.

The FDA's approval was based on outcomes from the ADvocate1 and ADvocate2 trials, as well as the phase 3 ADhere study. The ADvocate trials assessed Ebglyss as a standalone treatment in adults and adolescents with moderate-to-severe AD, while ADhere evaluated the drug in conjunction with topical corticosteroids.

Results from these trials demonstrated that by week 16, 38% of patients receiving Ebglyss in ADvocate 1 and 2 achieved clear or almost-clear skin, compared to only 12% in the placebo group. Additionally, some patients (10%) showed significant improvement as early as week four. Remarkably, 77% of patients who achieved clear or almost-clear skin by week 16 maintained these results for one year with monthly dosing.

Furthermore, patients treated with Ebglyss experienced notable itch relief as early as week two. At week 16, 85% of those who experienced itch relief maintained this benefit with continued monthly maintenance dosing for a year.

Daniel Skovronsky, the chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, emphasized the impact of eczema on daily life due to its unpredictable symptoms. He highlighted that Ebglyss offers a targeted approach to mitigating the primary cause of eczema inflammation, providing long-lasting symptom relief with the convenience of a once-monthly maintenance dose.

Eli Lilly holds exclusive rights to develop and commercialize Ebglyss in the US and globally, excluding Europe. In Europe, the rights for development and commercialization of the drug for dermatological applications have been licensed to Almirall.

This FDA approval of Ebglyss represents a significant advancement in the treatment options available for individuals struggling with moderate-to-severe atopic dermatitis, offering a new hope for long-term symptom management and improvement in quality of life.