Almirall gains EC approval of Ebglyss for moderate-to-severe atopic dermatitis
Almirall has announced that the European Commission (EC) has approved Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients over the age of 12 with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.
The drug is a monoclonal antibody which binds IL-13 with high affinity to prevent the production of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, in order to inhibit the biological effects of IL-13. This cytokine is key in AD, driving the type-2 inflammatory loop in the skin and leading to skin barrier dysfunction, itch, skin thickening and infection.
The approval of this drug marks a step forward in treatment of moderate-to-severe AD not controlled by topical therapies due to the selective mechanism of action, and has proven short and long-term efficacy and safety up to two years.
Dr Volker Koscielny, chief medical officer at Almirall, commented: “The EC approval of lebrikizumab for people suffering with moderate-to-severe AD provides another much-needed treatment option for this challenging disease. We are confident that due to its demonstrated short and long-term efficacy, with monthly maintenance dosing and a consistent safety profile, it has the potential to become a first-line biologic treatment. This regulatory milestone again highlights Almirall’s commitment to develop innovative treatments that can make a meaningful difference in the lives of people with skin diseases.”
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