Regeneron Receives EMA’s CHMP Positive Opinion Recommending Approval of Dupixent (dupilumab) for Eosinophilic Esophagitis
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending approval of Dupixent for adults and adolescents with EoE. The EC’s decision is expected in the coming months
- The opinion was based on the 52wk. results from a P-III trial consisting of 3 parts (Part A in 81 patients), Part B (240 patients) & Part C evaluating Dupixent (300mg, qw) vs PBO for 24wks.
- The results showed an improvement in the ability to swallow as early as 4wks. as well as histological disease remission, improvements in abnormal endoscopic findings of the esophagus & cellular improvements @24wks. with outcomes maintained ~1yr. The safety results were consistent with the known safety profile of Dupixent in its approved indications
Ref: PRNewswire | Image: Regeneron
Related News:- Regeneron Receives EMA’s CHMP Positive Opinion of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis
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