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Thursday 22 August 2019
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Dupilumab approved by EC for adolescents with moderate-to-severe atopic dermatitis

The European Commission has extended the marketing authorisation for Dupixent® (dupilumab) in the European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Dupixent is now the first biologic medicine approved in the EU to treat these patients.
 
Moderate-to-severe atopic dermatitis can affect many aspects of an adolescent’s life, including their physical and emotional well-being,” said Christine Janus, Chief Executive Officer of the International Alliance of Dermatology Patient Organizations. “This disease places an immense burden not only on the young people living with it but also the family members who care for them. We welcome the addition of new treatment options to help adolescents control and manage an often debilitating disease.”

Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease. In its moderate-to-severe form, it is characterized by rashes that can potentially cover much of the body, and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing. Inadequately controlled atopic dermatitis can have a physical, emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression, and feelings of isolation. Despite standard-of-care therapy, there continues to be an unmet need for many adolescents with moderate-to-severe atopic dermatitis who often have uncontrolled, persistent symptoms.

Adolescents with moderate-to-severe atopic dermatitis in the EU now have an approved biologic medicine that can significantly control persistent, debilitating symptoms like itch and skin lesions, as well as improve sleep, which is particularly critical during these formative years,” said George D Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. “Today’s approval also provides these young patients with a treatment option that addresses the type 2 inflammation that underlies atopic dermatitis. In addition to its approved uses in atopic dermatitis and asthma in the EU, we continue to investigate Dupixent in a broad range of patients with other type 2 inflammatory diseases.”

Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, as well as asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP is currently under review in the EU).

Adolescents with inadequately controlled moderate-to-severe atopic dermatitis face a certain set of challenges that can have a lasting impact on their lives. The physical and psychological symptoms of moderate-to-severe atopic dermatitis can prevent adolescents from fully participating in activities with their peers, including school, sports and hobbies, and can often place a serious burden on family members,” said John Reed, MD, PhD, Head of Research and Development at Sanofi. “From our Phase III trials, we know Dupixent significantly reduced itch, helped clear the skin, and improved health-related quality of life outcomes for adolescents at this critical period of their lives.”