Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III Trial for the Treatment of Eosinophilic Esophagitis

Shots:

• The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks.
• The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved histological disease remission (59% vs 6%); safety results were consistent with the known safety profile of Dupixent in its approved indications; overall rates of AEs (84% & 71%)
• The results are expected to be submitted to regulatory authorities by 2022. Additionally, the therapy has received BT designation from the US FDA for patients aged 12yrs. with EoE in Sept’20

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