Regeneron and Sanofi Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Eosinophilic Esophagitis
- The EC has expanded the marketing authorization for Dupixent in adults & adolescents aged ≥12yrs. The EC’s decision was based on the 52wk. results from a P-III trial consisting of 3 parts i.e., parts A, B, C (n=42, 79, 188) evaluating Dupixent (300mg, qw) vs PBO for 24wks.
- The part A & B results showed ~10 times higher rate of histological remission (60% & 59% vs 5% & 6%); reduction in disease symptoms (69% & 64% vs 32% & 41%), clinical improvement (21.9 & 23.8-point vs 9.6 & 13.9-point)
- ≥7-fold reduction in abnormal endoscopic (-3.2 & -4.5 points vs -0.3 & -0.6 points), improvement in swallowing-related pain & health-related QoL & less frequent non-swallowing symptoms while long term efficacy in part C was similar to parts A & B results
Ref: GlobeNewswire | Image: Regeneron
Related Post: Regeneron Receives EMA’s CHMP Positive Opinion Recommending Approval of Dupixent (dupilumab) for Eosinophilic Esophagitis
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