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
| Ref: Regeneron | Image: The Print
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