Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis

發(fā)布時間： 2024-11-11 閱讀：383次

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November 17, 2024 – Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis.

The approval is based on the two-part (Part A and B) EoE KIDS phase 3 study in children aged one to 11 years, which established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent populations.

EoE is a chronic, progressive disease associated with type-2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions leading to delays in diagnosis. EoE can severely impact a child’s ability to eat and may also cause vomiting, abdominal pain, difficulty swallowing, decreased appetite, and challenges thriving.