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

Core Insights - Dupixent (dupilumab) has been approved by the European Medicines Agency as the first and only treatment for eosinophilic esophagitis (EoE) in children aged one to eleven years, addressing a significant unmet medical need in this population [1][3][5] Summary by Sections Approval and Indication - The approval of Dupixent is based on phase 3 clinical trial data demonstrating that 68% of children treated with Dupixent achieved histological disease remission at 16 weeks, compared to only 3% in the placebo group [3][7] - Dupixent is indicated for children who weigh at least 15 kg and are inadequately controlled by or intolerant to conventional therapies [1][3] Clinical Study Details - The EoE KIDS study included two parts: Part A evaluated Dupixent's efficacy over 16 weeks, while Part B provided a 36-week extended treatment period [7][8] - Key outcomes from Part A showed an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline, alongside significant improvements in endoscopic findings and disease severity [3][8] Safety Profile - The safety profile of Dupixent in the EoE KIDS study was consistent with its known profile in older populations, with common adverse reactions including injection site reactions and conjunctivitis [4][10] - In children aged one to eleven, adverse events observed more frequently with Dupixent included COVID-19, nausea, injection site pain, and headache [4][10] Market Context - Eosinophilic esophagitis is a chronic disease that can severely impact a child's ability to eat, leading to nutritional challenges during critical growth periods [6][5] - Dupixent's approval represents a significant advancement in treatment options for pediatric patients who previously had no specifically approved therapies for EoE [3][5] Company Background - Dupixent is developed jointly by Sanofi and Regeneron, with a focus on treating various diseases driven by type-2 inflammation [12][14] - The drug has received regulatory approvals in over 60 countries for multiple indications, with more than 1,000,000 patients currently treated globally [11][12]