Sanofi: thumbs up from CHMP for dermatitis drug
(CercleFinance.com) - Sanofi has announced that the CHMP of the European Medicines Agency has recommended the extension of the indications of Dupixent (dupilumab) in the European Union to the treatment of severe atopic dermatitis in young children aged six months and older.
This opinion is based on data from a Phase III trial which showed that Dupixent improved skin healing, reduced overall disease severity and improved health-related quality of life in children aged six months to five years.
In Europe, approximately 80,000 children in this age group with this disease are candidates for systemic treatment. If approved, Dupixent will be the first and only targeted drug available in the EU for the treatment of these young children.
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