Sanofi and Regeneron Pharmaceuticals Inc. said the European Commission approved Dupixent for treating adolescent patients with a certain skin disease.
The extended approval allows the use of Dupixent, or dupilumab, to treat moderate-to-severe atopic dermatitis in patients aged 12 to 17 years who are candidates for systemic therapy. Atopic dermatitis is a common chronic inflammatory skin disease characterized by red and itchy skin.
Dupixent is the first biologic medicine approved in the EU to treat these patients.
The extended approval was backed by results of the Liberty AD clinical program in which patients treated with Dupixent demonstrated at least 75% improvement in the disease's extent and severity. Additionally, 42% of patients showed 75% or greater skin improvement compared to placebo.
In the U.S., Dupixent is already approved for the same indication, as well as to treat chronic rhinosinusitis with nasal polyps and as an add-on maintenance therapy for moderate-to-severe asthma in certain patients.
Tarrytown, N.Y.-based Regeneron and France's Sanofi are evaluating Dupixent in a range of clinical development programs for diseases driven by allergic and other kinds of inflammation.