Tuesday, April 16, 2024

FDA Grants Priority Review for Dupixent® (dupilumab) sBLA Seeking Approval for Eosinophilic Esophagitis Treatment in Children Aged 1 to 11

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The U.S. Food and Drug Administration (FDA) has accepted the Priority Review of a supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) aimed at treating children aged 1 to 11 with eosinophilic esophagitis (EoE). Dupixent is currently the only FDA-approved treatment for individuals aged 12 and above with EoE who weigh at least 40 kg. If this sBLA is approved, Dupixent will become the first and only treatment option for children aged 1 to 11 with EoE in the United States. EoE is a chronic condition characterized by type 2 inflammation that damages the esophagus and hampers eating.

The sBLA relies on data from the Phase 3 EoE KIDS trial (Parts A and B), which assessed Dupixent’s efficacy and safety in children aged 1 to 11 with EoE. In Part A of the trial, Dupixent demonstrated success in achieving histological disease remission compared to a placebo. Part B, an extension of the active treatment period, showcased Dupixent’s ability to maintain histologic remission for 52 weeks. Safety results were generally consistent with Dupixent’s known safety profile.

The FDA’s decision is expected by January 31, 2024. About 9,000 of the 21,000 children under 12 being treated for EoE in the U.S. do not adequately respond to available therapies, highlighting the need for advanced treatment options.

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