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Sanofi:EU Oks Dupixent For Adolescents With Moderate-to-Severe Atopic Dermatitis

Sanofi (SNYNF,SNY) and Regeneron Pharmaceuticals Inc. (REGN) said Tuesday that the European Commission extended the marketing authorization for Dupixent or 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.

Moderate-to-severe atopic dermatitis can affect many aspects of an adolescent's life, including their physical and emotional well-being.

Sanofi and Regeneron are jointly developing Dupilumab under a global collaboration agreement.

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.

In a separate press release, Regeneron and Sanofi said that a pivotal Late-stage trial evaluating Dupixent to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints.

In the U.S., Dupixent is currently approved in patients 12 years and older with moderate-to-severe atopic dermatitis, as well as moderate-to-severe asthma and adults with severe chronic rhinosinusitis with nasal polyposis.

The data show that for children with severe atopic dermatitis--covering nearly 60% of their skin surface on average--, adding Dupixent to standard-of-care topical corticosteroids or TCS significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone.

In addition, the safety data were consistent with the previously documented safety profile of Dupixent in older populations, including a numerically lower rate of skin infections compared to placebo.

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