Sanofi and Regeneron Reports the EC’s Approval of Dupixent (Dupilumab) for Young Children with Eosinophilic Esophagitis (EoE)
Shots:
- The EC has approved Dupixent to treat EoE in children (1-11yrs., at least 15kg), inadequately controlled by, intolerant to, or those ineligible for conventional therapy, based on the P-III (EoE KIDS) study
- The P-III study assessed Dupixent vs PBO among EoE children, with part A involving 71 patients receiving weight-based doses for 16wks., followed by an extended 36wks. part B involving eligible ones from part A in both the Dupixent & PBO group
- Study showed histological remission in 68% vs 3% at 16wks. (sustained for 1yr. in part B), 86% reduced peak esophageal intraepithelial eosinophil count vs 21% increase, decreased endoscopic & disease severity plus improved frequency & severity of EoE symptoms. Data published in the NEJM
Ref: Regeneron | Image: Sanofi & Regeneron
Related News:- Sanofi and Regeneron’s Dupixent Receives the US FDA’s and NMPA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
