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Sanofi: new approval for Dupixent

(CercleFinance.com) - Sanofi has announced that the European Commission has approved Dupixent (dupilumab) in the European Union for the treatment of severe atopic dermatitis in children aged six months to five years, who are candidates for systemic therapy.


With this approval, the third granted to Dupixent by Brussels in the last four months, Dupixent becomes the first and only targeted medicine indicated for the treatment of children in this age group in Europe and the US.

Dupixent is now a treatment option for nearly 80,000 infants and young children with severe uncontrolled atopic dermatitis in Europe, the French pharmaceutical group said.

The approval was based on a Phase III trial, which, amongst other things, showed that about seven times more patients treated with Dupixent had normal or near-normal skin, with a reduction in overall disease severity, compared with placebo.


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