Sanofi: favourable CHMP opinion for Dupixent
(CercleFinance.com) - Sanofi announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a favourable opinion on the request to extend indications for Dupixent (dupilumab).
Based on the clinical trial results, the CHMP has recommended the approval of this medicine in the European Union, for the treatment of severe atopic dermatitis in children aged six to eleven years who are candidates for systemic therapy.
Dupixent could become the first biologic approved in the EU for this type of patient. Data further reinforce the well-established safety profile observed in adult and adolescent atopic dermatitis patients.
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