Sanofi and Regeneron gain pediatric nod for Dupixent
The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children with eosinophilic esophagitis.
The nod makes Dupixent the first and only medicine approved in the USA specifically for this group of patients, and adds to an initial nod for patients aged 12 and over.
In a statement, developer Sanofi (Euronext: SAN) noted that the FDA undertook its assessment under the Priority Review scheme, which is reserved for medicines that represent potentially significant improvements in efficacy or safety for serious conditions.
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