Regeneron: Phase 3 Trial Of Dupixent In Children With Eosinophilic Esophagitis Meets Main Goal

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNYNF, SNY) said that a phase 3 trial, which assessed the investigational use of Dupixent or dupilumab in children aged 1 to 11 years with eosinophilic esophagitis, met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens.

In the phase 3 trial, 102 children aged 1 to 11 were randomized to receive Dupixent, in either a higher dose (n=37) or lower dose (n=31) regimen based on body weight, or placebo (n=34).

At 16 weeks, 68% of children on higher dose and 58% of patients on lower dose Dupixent achieved the primary endpoint of significant histological disease remission compared to 3% of children on placebo.

Eosinophilic esophagitis is a chronic inflammatory disease that damages the esophagus and prevents it from working properly.

In May 2022, the U.S. Food and Drug Administration approved Dupixent 300 mg weekly to treat patients with eosinophilic esophagitis aged 12 years and older and weighing at least 40 kg after granting the medicine Priority Review.

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