Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis
Sanofi’s interleukin-4 and -13 inhibitor Dupixent (dupilumab) has been given the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the treatment of severe atopic dermatitis, when combined with topical corticosteroids (TCS).
The backing is specific to patients between the ages of six and 11 who are eligible for systemic therapy.
The recommendation was based on Phase 3 data demonstrating that Dupixent “significantly improved” skin clearance, itch and health-related quality of life measures and measures of overall disease severity according to the Eczema Area and Severity Index), when compared to TCS monotherapy. A final decision on European approval is expected in the next few months.
Dupixent is currently approved in Europe for uncontrolled moderate-to-severe atopic dermatitis in patients over the age of 12 and in the US in patients older than six years old. It is the only biologic approved in these indications in those regions.
In Europe, the drug is also authorised for the treatment of severe asthma and severe chronic rhinosinusitis with nasal polyps in specific patient populations.
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