Eli Lilly and Company has announced FDA approval of EBGLYSS (lebrikizumab-lbkz) to treat moderate-to-severe atopic dermatitis in adults and children aged 12 and older.
The new IL-13 inhibitor is designed for patients who have not found relief from topical prescriptions.
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By GlobalDataEBGLYSS, an injection targeting eczema inflammation, can be administered with or without topical corticosteroids.
The treatment begins with a 500mg dose at week 0 and week 2, followed by a 250mg dose every two weeks until week 16. Upon achieving a satisfactory clinical response, the regimen shifts to a single monthly maintenance injection.
Data from the ADvocate 1, ADvocate 2 and ADhere clinical trials influenced the FDA’s decision.
The trials involved more than 1,000 adult subjects and children with moderate-to-severe eczema, assessing EBGLYSS in achieving clear or almost clear skin after 16 weeks of treatment.
Lilly Immunology president and Lilly Research Laboratories chief scientific officer and president Daniel Skovronsky stated: “People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives.
“Today’s approval allows people the opportunity to re-imagine 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 is preparing to launch the treatment in the US market and is working with stakeholders to ensure patient access to the medication.
Lilly Support Services for EBGLYSS will also provide a patient support programme, including co-pay assistance for eligible patients.
Following its approval in the European Union in 2023 and Japan in January 2024, EBGLYSS is set to expand into additional markets towards the end of 2024.
While Lilly has exclusive rights for its global development and commercialisation outside Europe, its partner Almirall is licensed to commercialise the treatment for dermatological conditions, including eczema, in Europe.
In July 2024, the National Institute for Health and Care Excellence (NICE) recommended EBGLYSS (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option.
