Sanofi, Regeneron Win Dupixent Label Expansion to Treat Eosinophilic Esophagitis

Sanofi and Regeneron have received FDA approval for Dupixent (dupilumab) as the first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE). EoE is a disease driven by type 2 inflammation that impacts the ability to eat. The approval was based on the EoE KIDS phase 3 trial, which showed a greater proportion of children taking Dupixent achieved histological disease remission compared to those on placebo.

Dupixent is currently approved to treat five inflammatory disorders, and the companies have been working to expand its use to children. In June 2022, the FDA approved Dupixent to treat children between the ages of 6 months and 5 years, and in 2023, it was approved for children between the ages of 6 and 11 with asthma. The drug has shown potential to transform the standard of care for children with EoE by targeting the underlying type 2 inflammation that contributes to the disease.