Almirall gains EC approval of Ebglyss for moderate-to-severe atopic dermatitis

Betsy Goodfellow | November 20, 2023 | News story | Medical Communications Almirall, Dermatology, Ebglyss, European Commission, 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.”

Betsy Goodfellow

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