(AOF) – The pharmaceutical company Sanofi announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a favorable opinion on the application for extension of the indications of Dupixent ( dupilumab) and recommended its approval in the European Union for the treatment of severe atopic dermatitis in children aged 6 months to 5 years who are candidates for systemic therapy.
The European Commission is expected to announce its final decision on this indication in the coming months, Sanofi said in a statement.
In June 2022, the drug Dupixent was approved by the Food and Drug Administration (FDA), the American health authority, for children in this age group, recalled the French group.
The use of Dupixent for the treatment of atopic dermatitis in infants and young children under 6 is experimental in the European Union and has not yet been approved, Sanofi added.
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