Regeneron Pharmaceuticals, Inc. announced the New England Journal of Medicine(NEJM) has published results from a positive Phase 3 trial for Dupixent® (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Data from the trial were the basis for the U.S. Food and Drug Administration (FDA) Priority Review and approval of Dupixent in children aged 1 to 11 years with EoE weighing at least 15 kg, as well as for the regulatory submission that is currently under review by the European Medicines Agency for this age group.

EoE is a chronic, progressive disease associated with type 2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can severely impact a child?s ability to eat and may also cause abdominal pain, trouble swallowing, heartburn, vomiting and failure to thrive.

Continuous management of EoE may be needed to reduce the risk of complications and disease progression. Safety results were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Adverse events more commonly observed with Dupixent (³10%) in either weight-based dosing regimen versus placebo in the trial were COVID-19, nausea, injection site pain and headache during Part A. The long-term safety profile of Dupixent in children aged 1 to 11 years through Part B was similar to that observed during Part A. In Part B, one case of helminth infection was reported with Dupixent.

For patients in the U.S. with EoE weighing at least 15 kg., the FDA-approved dosage for Dupixent is 200 mg or 300mg every other week, or 300mg weekly, based on weight.