Sanofi: priority review for Dupixent for children
(CercleFinance.com) - Sanofi announces that the US FDA has granted priority review to the supplemental Biologics License Application (sBLA) for Dupixent for the treatment of eosinophilic esophagitis in children aged 1 to 11 years.
The FDA is set to announce its decision on 31 January 2024. This license application is based on data from the Phase III EoE KIDS trial, which evaluated the efficacy and safety of Dupixent in children in this age group suffering from this disease.
If approved, Dupixent will be the first and only drug indicated in the US for children aged 1 to 11 affected by this inflammatory signature type 2 disease, which results in feeding difficulties.
Of the 21,000 children under the age of 12 currently being treated in the US for eosinophilic esophagitis, nearly 9,000 are not responding satisfactorily to unapproved therapies, Sanofi said.
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