Eli Lilly/Almirall report positive long-term Ebglyss results in atopic dermatitis

Eli Lilly and Almirall have reported encouraging long-term outcomes for their IL-13 inhibitor, Ebglyss (lebrikizumab-lbkz), in treating moderate-to-severe atopic dermatitis (AD). The ADjoin long-term extension study assessed two dosing schedules of the drug in patients who had completed 52 weeks in the phase 3 ADvocate 1 or 2 trials.

The results, to be showcased at the European Academy of Dermatology and Venereology Congress, revealed that 84% of patients receiving Ebglyss once monthly and 83% of those on a bi-weekly regimen sustained clear or nearly clear skin over three years. Moreover, 87% of patients on a monthly dose and 79% on a bi-weekly dose exhibited or maintained at least a 90% reduction in the severity and extent of the disease after three years. Additionally, high-potency topical corticosteroids or systemic treatments were unnecessary for 83% and 91% of patients in the respective dosing groups.

Atopic dermatitis, commonly known as eczema, is an inflammatory skin condition characterized by itchiness, dryness, and cracking. It affects approximately 7.3% of adults in the United States, with around 40% experiencing moderate to severe symptoms. Mark Genovese, senior vice president of immunology development at Lilly, commented on the findings: "Without adequate treatment, AD can leave people struggling with uncontrolled symptoms… This three-year data demonstrates that Ebglyss given once monthly provides durable symptom relief for patients who need it most."

These promising findings come shortly after the US Food and Drug Administration approved Ebglyss for treating moderate-to-severe AD in adults and adolescents aged 12 and older, weighing at least 40kg, whose condition remains uncontrolled by topical prescription therapies. Additionally, the National Institute for Health and Care Excellence recently recommended the drug for use in the NHS in England and Wales. Ebglyss also received approval from the European Commission last year.

Eli Lilly holds exclusive development and commercialization rights for Ebglyss in the United States and worldwide, except for Europe, where Almirall has licensed the rights for dermatology applications.