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The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
The European Commission (EC) has approved an extension of the use of Dupixent (dupilumab) within the European Union (EU) to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis, Sanofi announced in an Aug. 6, 2019 press statement.
With this approval, Dupixent, which is a fully human monoclonal antibody, has become the only biologic approved within the EU to treat adolescents with moderate-to-severe atopic dermatitis. The commission’s approval was based on the results from a Phase III clinical trial that demonstrated safety and efficacy of the treatment.
“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, president and chief scientific officer at Regeneron, in the press release. “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.”
“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,” added John Reed, head of R&D 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.”
Dupixent is being jointly developed by Sanofi and Regeneron as part of a global collaboration agreement.