European Commission Approves EBGLYSS (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

Biopharmaceutical company, Almirall, recently announced in a press release that the European Commission (EC) has granted approval for EBGLYSSⓇ (lebrikizumab) for moderate-to-severe atopic dermatitis (AD) in patients 12 years and older.


Lebrikizumab is a monoclonal antibody that inhibits IL-13 signaling and its approval is based on three Phase 3 clinical studies, ADvocate 1, ADvocate 2, and ADhere.

ADvocate 1 and 2 evaluated lebrikizumab as monotherapy and found that by week 16, the extent and severity of AD had reduced by at least 75% in almost 6 out of 10 patients. In ADhere, which assessed lebrikizumab in combination with topical corticosteroids (TCS), this result was achieved in almost 7 out of 10 patients. Furthermore, almost 80% of the week 16 responders who continued treatment as both monotherapy and in combination with TCS for up to two years experienced sustained skin clearance, itch relief, and reduced AD severity with monthly maintenance dosing.

The studies also evaluated the safety of lebrikizumab and results revealed that most of the adverse events were mild or moderate and did not lead to the discontinuation of treatment. The most common adverse events included conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

Speaking of the recent approval, the chief medical officer at Almirall, Dr.Volker Koscielny, states, “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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