The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis (AD) in adult and adolescent patients (12 years and older, weighing at least 40kg) whose disease is not adequately controlled with topical prescription therapies. This approval marks a significant advancement in the treatment landscape for atopic dermatitis, a chronic inflammatory skin condition affecting a substantial portion of the U.S. population.
Efficacy and Clinical Trial Data
The FDA's decision was supported by data from three key clinical trials: ADvocate1, ADvocate2, and ADhere. The ADvocate1 and ADvocate2 trials evaluated Ebglyss as a monotherapy, while the ADhere study assessed its efficacy in combination with topical corticosteroids. These trials demonstrated significant improvements in skin clearance and itch relief among patients treated with Ebglyss.
At week 16, 38% of patients treated with Ebglyss in the ADvocate 1 and 2 trials achieved clear or almost-clear skin, compared to 12% of those receiving placebo. Notably, 10% of Ebglyss-treated patients experienced these results as early as week four. Among patients who achieved clear or almost-clear skin at week 16, 77% maintained these results at one year with once-monthly dosing.
Patients also reported meaningful itch relief as early as week two, with 85% of those achieving itch relief at week 16 maintaining that relief at one year with monthly maintenance dosing.
Mechanism of Action and Dosing
Ebglyss is a targeted interleukin-13 (IL-13) inhibitor, designed to block the IL-13 pathway, a key driver of inflammation in atopic dermatitis. The drug can be used with or without topical corticosteroids and is administered as a single monthly maintenance injection following an initial treatment phase.
Impact and Perspective
Atopic dermatitis, commonly known as eczema, affects 7.3% of adults in the U.S., with approximately 40% experiencing moderate to severe symptoms. The chronic itch, dry skin, and inflammation associated with AD can significantly impair quality of life.
Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories, emphasized the impact of the approval, stating, "People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives... [This] approval allows people the opportunity to reimagine life with eczema as Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation. Ebglyss provides long-lasting symptom relief with a convenient once-monthly maintenance dose."
Lilly holds exclusive rights for the development and commercialization of Ebglyss in the U.S. and the rest of the world outside of Europe, where Almirall has licensed the rights.
