Regeneron Pharmaceuticals Inc. (REGN) and Sanofi have announced that the European Commission has granted approval for Dupixent (dupilumab) to be utilized in the treatment of eosinophilic esophagitis (EoE) in pediatric patients as young as one year old.
This approval specifically pertains to children aged between 1 and 11 years who have a minimum weight of 15 kg and who remain inadequately controlled by existing therapies, or are intolerant to them, or do not qualify for conventional medicinal treatments.
This decision expands the initial authorization within the European Union for the treatment of EoE in adults and adolescents, positioning Dupixent as the first and only medication approved for this younger patient population. Further, Dupixent has also received approval for use in this age group in the United States and Canada.
The EoE KIDS Phase 3 trial was conducted as a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Dupixent in children aged one to eleven years with EoE. The safety outcomes reported in the EoE KIDS trial were consistent with the established safety profile of Dupixent in both adolescents and adults diagnosed with EoE.
Dupixent, jointly developed by Regeneron and Sanofi under a global collaboration agreement, is an injection administered under the skin (subcutaneous injection) at different injection sites. Dupixent, which was invented using Regeneron's proprietary VelocImmune technology, 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.
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