Tuesday, April 16, 2024

Dupixent® Phase 3 Results Demonstrate Sustained Efficacy for One Year in Children with Eosinophilic Esophagitis (EoE)

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Positive results from a Phase 3 clinical trial have demonstrated the sustained efficacy and safety profile of Dupixent® (dupilumab) for up to one year in children aged 1 to 11 years with eosinophilic esophagitis (EoE). EoE is a chronic and debilitating condition that affects children, causing persistent difficulties with eating, abdominal pain, and failure to thrive. These findings, presented during a late-breaking session at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting, represent the first analysis of longer-term data in this age group.

The late-breaking data featured results from children enrolled in the extended active treatment period of a Phase 3 trial, following 16 weeks of Dupixent treatment or placebo. All children were treated with either a higher or lower dose of Dupixent for an additional 36 weeks, resulting in up to 52 weeks of data.

Key findings from the study include:

  • Sustained efficacy in children with EoE.
  • Significant improvements in histological and endoscopic outcomes.
  • Positive caregiver-reported signs and symptoms.
  • A notable increase in body weight for the age percentile.

The safety results for children receiving Dupixent were generally consistent with the known safety profile of the medication. Adverse events, including mild to moderate cases of COVID-19, injection site reactions, cough, and headaches, were reported in a small percentage of patients.

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for higher dose Dupixent to treat children aged 1 to 11 years with EoE, and it is currently under Priority Review. If approved, Dupixent would become the first and only FDA-approved treatment for these children with EoE.

These findings reinforce the potential of Dupixent as a treatment for EoE in children, providing sustained efficacy and safety, which is crucial for improving the quality of life for these young patients suffering from this condition. The study underscores the importance of targeting key pathways driving inflammation in EoE, and Dupixent, by inhibiting the IL-4 and IL-13 pathways, has shown great promise in addressing this unmet medical need.

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