Sanofi announces that the FDA has approved its Dupixent for the treatment of eosinophilic esophagitis in children aged 12 months and older, weighing at least 15 kg, making it the only drug approved in the U.S. for this category of patients.

This approval is based on the results of the Phase III EoE KIDS trial, which showed that a greater proportion of children treated with Dupixent achieved histological remission compared to placebo.

This approval extends the one granted by the FDA in May 2022 for patients aged 12 and over and weighing at least 40 kg. Eosinophilic esophagitis is the fifth indication modulated by underlying type 2 inflammation to be approved for Dupixent in the U.S.

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