French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) said on Tuesday that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 years.

Dupixent is currently the only treatment in the US approved for adults and children aged 12 years and older (weighing at least 40kg) with EoE, a condition driven by type 2 inflammation that hampers eating.

Approximately 21,000 children under 12 years old in the US are currently receiving treatment for EoE. Of these, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced alternative treatments.

The sBLA is supported by data from the Phase 3 EoE KIDS trial, including Parts A and B, which evaluated Dupixent's efficacy and safety in children aged 1 to 11 with EoE. Key results indicate that Dupixent maintained histological disease remission for 52 weeks, demonstrating its potential to provide a new treatment option for this patient group. Safety outcomes align with Dupixent's known safety profile for its FDA-approved EoE indication in older children and adults.

Priority Review status is granted to therapies that could significantly enhance the management, diagnosis or prevention of serious conditions.

EoE causes esophageal damage and eating difficulties, especially in children, who may experience symptoms such as heartburn, vomiting and food-related anxiety. Current treatments mainly involve dietary adjustments, including eliminating certain foods, and using therapies not approved for EoE. Dupixent, if approved, could provide a vital alternative for young EoE patients.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.